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Two with the AEs, dyspnea and chest pain, have been documented as “significant” and “severe,” respectively and transpired in exactly the same subject matter. All Other people ended up claimed as gentle or reasonable. Inside of a clinical trial there have been reports of renal dysfunction, urinary program Ailments and deaths in the review inhabitants. None of these are already verified to generally be affiliated with Progel™ PALS.

Within a pivotal clinical demo there have been 3 topics inside the Progel™ PALS group with AEs which were deemed through the investigator to become maybe or possibly connected with the unit. The AEs reported ended up: chest suffering, constipation, gastroesophageal reflux, nausea, cough, dyspnea, pneumothorax, and subcutaneous emphysema. All had been described as a single incidence in the Progel™ PALS team.

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Tend not to use Progel™ PALS on oxidized regenerated cellulose, absorbable gelatin sponges or some other surface apart from visceral pleura as adherence and intended outcome may very well be compromised.

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Nearly all SAEs were being pulmonary and anticipated events as Section of a lung resection surgical treatment. Two people died over the program of your research, just one because of cardiac arrest and A different due to multi-program organ failure; neither ended up device connected or unanticipated.