MAUDE Adverse Event Report: GUNZE LIMITED THERAGENESIS; WOUND DRESSING WITH ANIMAL-DERIVED MATERIAL(S)

Model Number	TG-M82120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Burn patient under treatment; dermal matrix used; surgeon observed that the matrix did not produce the desired effect, suspecting therapeutic ineffectiveness and treatment delay.
Additional Manufacturer Narrative
The manufacturing and inspection records were reviewed and no abnormalities were identified.Although products of the same lot number and product code have already been distributed to four countries, no reports or notifications of similar events have been received.

• Brand Name: THERAGENESIS
• Common Device Name: WOUND DRESSING WITH ANIMAL-DERIVED MATERIAL(S)
• Manufacturer (Section D): GUNZE LIMITED; 46 natsumegaichi, aono; ayabe, kyoto 623-8 513; JA 623-8513
• Manufacturer (Section G): GUNZE LIMITED; 46, natsumegaichi, aono; ayabe, kyoto 623-8 513; JA 623-8513
• Manufacturer Contact: hidetoshi arimura ; jrwd dojima tower 5f, 2-4-27; dojima, kita-ku, osaka 530-0-003 ; JA 530-0003
• MDR Report Key: 23839539
• Report Number: 3010668881-2025-00003
• Device Sequence Number: 21193573
• Product Code: KGN
• UDI-Device Identifier: 04967162947207
• UDI-Public: 04967162947207
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K213498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: TG-M82120
• Device Lot Number: 240806P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/21/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown