MAUDE Adverse Event Report: LIFECELL STRATTICE PERFORATED 20 X 30; MESH, SURGICAL

Catalog Number 2030002P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Further information regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.

Event Description

Company representative reports strattice was used for abdomen bridging and site became swollen and seemed to be "fluffing off".Strattice was removed.

Manufacturer Narrative

Corrected data: g.1.A review of the device history record has been completed.No deviations or non-conformances noted.Qa investigation into lot sp200238 resulted in no remarkable findings and no deviations and no non conformances revealed.146 devices were released to finished goods and 136 have been distributed.Of the 136 distributed, no pieces have been reported as explanted.Lot sp200238 was terminally sterilized and met all qc release criteria including mechanical testing.

Event Description

Company representative reports strattice was used for abdomen bridging and site became swollen and seemed to be "fluffing off".Strattice was removed.

• Brand Name: STRATTICE PERFORATED 20 X 30
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ
• MDR Report Key: 11473409
• MDR Text Key: 246844694
• Report Number: 1000306051-2021-00020
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410012496
• UDI-Public: 00818410012496
• Combination Product (y/n): N
• PMA/PMN Number: K150712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 2030002P
• Device Lot Number: SP200238
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention