MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 30 X 30CM, FIRM; MESH, SURGICAL

Catalog Number 3030002

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

Patient Problems Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/29/2021

Event Type  Injury  

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported recurrence and failure to integrate with surgical intervention.Internal investigation into strattice lot sp100503 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of (b)(6) 2022, of the 235 devices released to finished goods for lot sp100503, 229 have been distributed with 131 reported as implanted.Based on our internal investigation with no remarkable findings, and without relevant patient factors, a relationship between the strattice and this event could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

Event Description

It was reported through a legal event that a 69 year old female patient had hernia repair surgery on or about (b)(6) 2017.During the hernia repair surgery, the surgeon implanted a strattice mesh; catalog number is 3030002 and lot number is sp100503-242.After surgery, the patient returned to the hospital on or about (b)(6) 2021, reporting sharp and cutting pain, nausea, and having to consistently wear abdominal binders.On or about (b)(6) 2021, the patient was diagnosed with abdominal pain and a recurrent hernia and underwent an exploratory laparotomy, excision of old mesh and abdomen closure.Upon surgical dissection, the surgeon noted failure of the mesh to incorporate into the tissue.The mesh was found adhered to a few spots in the left upper abdomen.The mesh was folded multiple times and wrinkled close to the area where she was experiencing severe pain.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 30 X 30CM, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 15158083
• MDR Text Key: 297210840
• Report Number: 1000306051-2022-00126
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410011796
• UDI-Public: 00818410011796
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 3030002
• Device Lot Number: SP100503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2022
• 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 Sex: Female