MAUDE Adverse Event Report: UNKNOWN STRATTICE; MESH, SURGICAL

Catalog Number UNK STRATTICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

The lot number(s) associated with this event remains unknown; therefore an internal investigation could not be performed.If additional information is received, a follow up report will be submitted within 30 calendar days.Without identification of the lot numbers(s), a relationship to the strattice was not determined.This report concludes our investigation at this time.

Event Description

This literature review is a 5 year follow up analysis on absorbable biologic mesh for complex abdominal wall reconstruction.This is a review of the longevity of those repairs comparing p4hb and porcine cadaveric mesh.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 12199096
• MDR Text Key: 267246782
• Report Number: 1000306051-2021-03045
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2021
• 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