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

Catalog Number	2030002P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Company representative reports strattice was used for abdomen bridging and site became swollen and seemed to be "fluffing off".Strattice was removed.
Additional 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 or Problem 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
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ
• MDR Report Key: 11473409
• Report Number: 1000306051-2021-00020
• Device Sequence Number: 4537005
• Product Code: FTM
• UDI-Device Identifier: 00818410012496
• UDI-Public: 00818410012496
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K150712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 2030002P
• Device Lot Number: SP200238
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention