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

Catalog Number XXX-SURGIMEND

Device Problem Material Integrity Problem (2978)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 an issue with the surgimend matrix thickness.No additional information was provided after several attempts.

Manufacturer Narrative

The surgimend matrix was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.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.

Event Description

N/a.

• 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: 12536323
• MDR Text Key: 273591251
• Report Number: 3004170064-2021-00005
• 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: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-SURGIMEND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2022
• 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