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

Catalog Number 2020002

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hernia (2240); Insufficient Information (4580)

Event Date 08/19/2016

Event Type  Injury  

Manufacturer Narrative

No lot information provided. If additional information is received a follow up will be submitted.

Event Description

Patient representative reported patient had strattice, implanted on (b)(6) 2015 for a hernia repair. Strattice was explanted on (b)(6) 2016. Lot number remains unknown.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 12041796
• MDR Text Key: 257488846
• Report Number: 1000306051-2021-03019
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 2020002
• Device Lot Number: SP100194
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2022
• 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 Treatment Data

Date Received: 06/22/2021 Patient Sequence Number: 1