MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 40, FIRM; MESH, SURGICAL

Catalog Number	2040002
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The internal investigation into lot sp200049 included a review of the reported information, review of the device history records and review of the complaint history records.Investigation results revealed no remarkable findings with no other complaints reported against the lot and no processing deviations.There was one unrelated nonconformance related to the nature of this complaint.The lot was aseptically processed, terminally sterilized within the process parameters and met all qc release criteria, including mechanical testing.As of date, of the (b)(4) devices released to finished goods for lot sp200049, (b)(4) have been distributed.No devices have been reported as implanted.Based on our internal review with no remarkable findings, a relationship between the strattice and this event could not be determined.No further actions are required as a nonconformance could not be confirmed.
Event or Problem Description
Healthcare professional reported the "patient was being extubated and began to cough.The physician heard a pop and could see that the mesh became dislodged" and "the suture basically cheese wired through the product and failed in 3-4 locations." strattice was removed and replaced.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 40, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 8277338
• Report Number: 1000306051-2019-00020
• Device Sequence Number: 1554927
• Product Code: FTM
• UDI-Device Identifier: 00818410010409
• UDI-Public: 00818410010409
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 09/30/2020
• Device Catalogue Number: 2040002
• Device Lot Number: SP200049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/25/2019
• 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