MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM; MESH, SURGICAL

Catalog Number	1010002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted, and thus, analysis of the device will not be possible.Multiple attempts were made to contact the reporter for additional information.No further information has been received.Internal investigation into lot # sp200011 is currently ongoing.The results will be reported in a supplemental medwatch.Based on the reported information relationship between the event and the strattice device cannot be determined.No further actions are required as a nonconformance could not be confirmed.
Event or Problem Description
Healthcare professional implanted a piece of strattice firm 10x10 in patient.There were no complications.Patient had a subsequent surgery in late june.Patient came into the clinic for a follow up visit, at which time healthcare professional found what they suspect to be unincorporated strattice protruding from the incision.
Additional Manufacturer Narrative
Internal investigation into lot sp200011 resulted in no remarkable findings including 167 devices released to finished goods, 157 have been distributed.Of the 157 distributed, 81 have been reported as implanted.The lot was aseptically processed, terminally sterilized, and met qc release criteria.There were no processing deviations or nonconformances related to the nature of this complaint.Several follow up attempts were sent to the reporter requesting additional information.To date, no response has been received.Based on the reported information relationship between the event and the strattice device cannot be determined.No further actions are required as a nonconformance could not be confirmed.
Event or Problem Description
Healthcare professional implanted a piece of strattice firm 10x10 in patient.There were no complications.Patient had a subsequent surgery in late june.Patient came into the clinic for a follow up visit, at which time healthcare professional found what they suspect to be unincorporated strattice protruding from the incision.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 10481919
• Report Number: 1000306051-2020-00044
• Device Sequence Number: 13764588
• Product Code: FTM
• UDI-Device Identifier: 00818410010096
• UDI-Public: 00818410010096
• Combination Product (Y/N): N
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: 06/30/2020
• Device Catalogue Number: 1010002
• Device Lot Number: SP200011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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