MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM; MESH, SURGICAL

Catalog Number 1620002

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

Patient Problem Hernia (2240)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

Internal investigation into strattice lot sp100388 included a review of the reported information, review of the device history records and review of the complaint history records.The device was not returned to lifecell for evaluation.Investigation results revealed no remarkable findings with no similar complaints reported against the lot and no related deviations or nonconformances revealed during manufacturing.The lot was terminally sterilized within the process parameters and met all qc release criteria.To date, of the (b)(4) devices released to finished goods for lot sp100388, (b)(4) have been distributed and 160 reported as implanted.

Event Description

Limited information was reported through legal, that a (b)(6) male patient underwent hernia repair surgery and was implanted with strattice lots sp100461-147 and sp100388-001 on (b)(6) 2016.On (b)(6) 2019 the patient had a repair of the recurrent ventral hernia with component separation and removal of previously placed mesh.This record is associated with lot sp100388-001 - record 2 of 2.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM
• Type of Device: MESH, SURGICAL
• MDR Report Key: 12752543
• MDR Text Key: 282202564
• Report Number: 1000306051-2021-03072
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410010010
• UDI-Public: 00818410010010
• Combination Product (y/n): N
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1620002
• Device Lot Number: SP100388
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NO INFORMATION
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR