MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM; MESH, SURGICAL

Catalog Number 2025002

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

Patient Problem Hernia (2240)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

Internal investigation into strattice lot s11210 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 other 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, all the (b)(4) devices released to finished goods for lot s11210 and 36 reported as implanted.

Event Description

Limited information was reported through legal, that a (b)(6) female patient underwent an incisional hernia repair on (b)(6) 2013.The patient was implanted with strattice lot s11210-053.The patient returned to the hospital 6 years later on (b)(6) 2019 and was diagnosed with a recurrent hernia and enterocutaneous fistula.On (b)(6) 2019 the patient had a repair of the recurrent ventral hernia and takedown of enterocutaneous fistula.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
• Type of Device: MESH, SURGICAL
• MDR Report Key: 12752551
• MDR Text Key: 282523707
• Report Number: 1000306051-2021-03073
• Device Sequence Number: 1
• Product Code: FTM
• 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: 2025002
• Device Lot Number: S11210
• 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: 56 YR