MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND MATRIX - UNSPECIFIED N/A

Catalog Number XXX-SURGIMEND

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

Patient Problems Unspecified Infection (1930); Seroma (2069)

Event Type  Injury  

Event Description

2 of 2 reports. Other mfg report number: (b)(4). A facility reported that after surgimend application, the patient had seroma, capsular contraction and infection requiring reoperation. The surgimend was used for breast reconstruction.

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

2 of 2 reports. Other mfg report number: 3004170064-2021-00013. A facility reported that after surgimend application, the patient had seroma, capsular contraction and infection requiring reoperation. The surgimend was used for breast reconstruction.

Manufacturer Narrative

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

• Brand Name: SURGIMEND MATRIX - UNSPECIFIED
• Type of Device: N/A
• 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: 12929461
• MDR Text Key: 285163439
• Report Number: 3004170064-2021-00014
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K071807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: XXX-SURGIMEND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown