MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND 4.0 25X40 CM

Catalog Number 606-400-016

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported a ventral hernia repair was performed on (b)(6) 2020 using surgimend 20x20 to repair the defect.The surgimend mesh implanted pulled through the fascia, product was starting to go away, and the patient re-herniated.The physician performed a ventral hernia revision on (b)(6) 2020 and implanted a surgimend 4.0 to repair the hernia.Physician confirmed the patient re-herniated again and 4 days later, the surgimend was melted and gone in certain areas.A culture was performed with a negative result for infection.Other mfg report number: 3004170064-2020-00007.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h6, h10 surgimend (product id 606-400-016) was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: SURGIMEND 4.0 25X40 CM
• Type of Device: SURGIMEND
• Manufacturer (Section D): TEI BIOSCIENCES INC; 7 elkins street; 7 elkins street; boston MA 02127
• MDR Report Key: 10432019
• MDR Text Key: 203832520
• Report Number: 3004170064-2020-00008
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K083898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 606-400-016
• Device Lot Number: 1808006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 03/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1