MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM; MESH, SURGICAL

Catalog Number	2030002
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Qa investigation is pending at this time.A supplemental medwatch will be submitted upon completion of device history review.
Event or Problem Description
Legal affairs reports patient underwent incisional hernia repair surgery.Strattice mesh implanted.Patient returned to hospital 1.5 years later because of abdominal wall abscess and unincorporated mesh requiring removal of the mesh.Mesh removed.
Additional Manufacturer Narrative
Qa investigation into lot sp100331 resulted in no remarkable findings and no deviations and no nonconformances revealed.181 devices were released to finished goods and 168 have been distributed.Of the 168 distributed, 80 have been reported as implanted.Lot sp100331 was terminally sterilized and met all qc release criteria including mechanical testing.
Event or Problem Description
Legal affairs reports patient underwent incisional hernia repair surgery.Strattice mesh implanted.Patient returned to hospital 1.5 years later because of abdominal wall abscess and unincorporated mesh requiring removal of the mesh.Mesh removed.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ
• MDR Report Key: 11427070
• Report Number: 1000306051-2021-00017
• Device Sequence Number: 2869450
• Product Code: FTM
• UDI-Device Identifier: 00818410010393
• UDI-Public: 00818410010393
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• 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: 11/30/2017
• Device Catalogue Number: 2030002
• Device Lot Number: SP100331
• 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: 03/07/2021
• 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