FDA Adverse Event
Malfunction
Summary report: N
EXSURCO MEDICAL AMALGATOME SD EXCISION RING BLAD
MDR report key: 25152265
·
Received May 12, 2026
Report
- Report Number
- MW5188046
- Event Type
- Malfunction
- Date Received
- May 12, 2026
- Date of Event
- April 22, 2026
- Report Date
- May 7, 2026
- Manufacturer
- EXSURCO MEDICAL, INC.
- Product Code
- GFD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ALAMGATOME BLADES ARE SITTING CROOKED AND MAKING A RATTLING NOISE WHEN IN USE. THE ALAMGATOME DAMAGED THE SKIN GRAFT, SHREDDING IT IN MULTIPLE AREAS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236125 | EXSURCO MEDICAL AMALGATOME SD EXCISION RING BLAD | DERMATOME | GFD | EXSURCO MEDICAL, INC. | 0 0810006 78007 9 | X-0000000000064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Male | Other |