MAUDE Adverse Event Report: TEI BioSciences Inc Surgimend matrix - unspecified; Surgical Recon - PRS & Hernia

Catalog Number	XXX-Surgimend
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Type of Reportable Event	Malfunction

• Brand Name: Surgimend matrix - unspecified
• Common Device Name: Surgical Recon - PRS & Hernia
• Manufacturer (Section D): TEI BioSciences Inc; 7 elkins street; 7 elkins street; boston MA 02127
• Manufacturer (Section G): TEI BioSciences Inc; 7 elkins street; boston MA 02127
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; +1(609)936-2319
• MDR Report Key: 50498967
• Report Number: 3004170064-2026-00028
• Device Sequence Number: 10087925
• Product Code: FTM
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: XXX-Surgimend
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown