MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTL

Catalog Number 606-907-001

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that when the medical staff opened the surgimend, they noticed that the edge was hard.They then rehydrated the product in room temperature saline water and noticed that there was excessive powder in the water and that there were filaments of tissue detached from the mesh which became fragile and friable while stretching and it broke up.No patient contact/injury reported and the event led to 35 minutes surgical delay.

Manufacturer Narrative

The surgimend mesh was returned for evaluation: the device was received to be degraded in a way that prevents evaluation/investigation of the alleged defect.Failure analysis could not be completed, root cause can not be determined at this time.Manufacturing records demonstrate that the device met specifications.A root cause can not be determined.This conclusion was made as the device received degraded far past the original state that the complaint was observed in.This type of defect can occur as a result of inadequate handling of the product, specifically during the hydration phase, however this can not be confirmed in this case.

Event Description

N/a.

• Brand Name: SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTL
• Type of Device: SURGIMEND
• Manufacturer (Section D): TEI BIOSCIENCES INC; 7 elkins street; 7 elkins street; boston MA
• MDR Report Key: 11965030
• MDR Text Key: 255110433
• Report Number: 3004170064-2021-00004
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K171357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606-907-001
• Device Lot Number: 2004012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1