FDA Adverse Event
Malfunction
Summary report: N
ADHERUS AUTOSPRAY ET DURAL SEALANT
MDR report key: 22282729
·
Received June 18, 2025
Report
- Report Number
- 22282729
- Event Type
- Malfunction
- Date Received
- June 18, 2025
- Date of Event
- June 10, 2025
- Report Date
- June 12, 2025
- Manufacturer
- HYPERBRANCH MEDICAL TECHNOLOGY, INC.
- Product Code
- NQR
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PRODUCT ASSEMBLED AND FUNCTIONED WELL FOR ABOUT 30 SECONDS. STOPPED FUNCTIONING AND PRODUCT WOULD NOT DISPENSE. NEEDED TO USE ADDITIONAL PRODUCT BECAUSE OF THIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1767529 | ADHERUS AUTOSPRAY ET DURAL SEALANT | SEALANT, DURAL | NQR | HYPERBRANCH MEDICAL TECHNOLOGY, INC. | NUS-109 | 10245863 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Female |