MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND MP 13 CM X 25 CM X 2MM

Catalog Number 606-206-003

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

Patient Problems Bacterial Infection (1735); Necrosis (1971)

Event Type  Injury  

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 a (b)(6) female patient with history of mid-abdominal and right lateral ventral hernia repair with plastic surgery reconstruction ((b)(6) 2021) developed an abdominal infection.The surgeon believe that the patient did not have a graft infection, but she developed necrosis of her abdominal wall at first week follow up after the surgery.She was treated by plastic surgery on (b)(6) 2021.On (b)(6) 2021, a bacterial culture was taken and showed positive for infection.The patient was treated with antibiotics.Product was not removed.

Event Description

N/a.

Manufacturer Narrative

Surgimend mp (606-206-003) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue 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 MP 13 CM X 25 CM X 2MM
• Type of Device: SURGIMEND
• Manufacturer (Section D): TEI BIOSCIENCES INC; 7 elkins street; 7 elkins street; boston MA
• Manufacturer (Section G): TEI BIOSCIENCES INC; 7 elkins street; boston MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12800270
• MDR Text Key: 282227682
• Report Number: 3004170064-2021-00012
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K162965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 606-206-003
• Device Lot Number: 2006008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2022
• Date Device Manufactured: 09/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female