|
Catalog Number 638005 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Unspecified Infection (1930)
|
Event Date 09/22/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported seprafilm was used in rectal cancer surgery in a patient who developed enteritis.On day after performing laparoscopic rectal resection/amputation (low anterior resection) or surgical support for rectal cancer, the physician noticed swelling on the patient¿s right lower leg, resulting from internal pressure in the right tibialis longus muscle area.The event of swelling on the patient¿s right lower leg was caused by an unrelated event distinct to the seprafilm¿s area of placement.The presentation of enteritis in relation to device placement is unknown.It was not reported if the patient was treated for enteritis.The patient¿s outcome was not reported.No additional information is available.
|
|
Manufacturer Narrative
|
Additional information: h6 and h10.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|