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

Catalog Number 2025002

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Adhesion(s) (1695); Hernia (2240)

Event Date 12/28/2018

Event Type  Injury  

Manufacturer Narrative

A investigation into lot s11242 resulted in no remarkable findings with no processing deviations or nonconformance's revealed.219 devices released to finished goods for lot s11242, 219 have been distributed.Of the 219 distributed, 97 have been reported as implanted.Lot s11242 was aseptically processed, terminally sterilized and met all qc release criteria.No other complaints reported for this lot.

Event Description

Patient representative reported that a male patient had strattice implanted for a hernia repair on (b)(6) 2013.Five years post operation, patient was diagnosed with adhesions, and an explant of the strattice on (b)(6) 2018.Lot number: s11242-081 and catalog 2025002.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 12061394
• MDR Text Key: 264860908
• Report Number: 1000306051-2021-03023
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 2025002
• Device Lot Number: S11242
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/24/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR