FDA Adverse Event
Malfunction
Summary report: N
ACTIPATCH
MDR report key: 23497822
·
Received November 7, 2025
Report
- Report Number
- MW5178629
- Event Type
- Malfunction
- Date Received
- November 7, 2025
- Report Date
- November 4, 2025
- Manufacturer
- BIOELECTRONICS CORPORATION
- Product Code
- PQY
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
SOME KIND OF BUG/INSECT FECAL MATTER IN DEVICE PACKAGING. TRAVELED ALL THE WAY TO MANUFACTURER ADDRESS FROM (B)(6) AND FOUND OUT MANUFACTURER IS NO LONGER AT THE BUILDING. ONLINE INFORMATION ON MANUFACTURER WEBSITE OR FDA DOES NOT STATE ANY NEW MANUFACTURER ADDRESS. PHONE CALL UNANSWERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186158 | ACTIPATCH | NONTHERMAL SHORTWAVE THERAPY DEVICE INDICATED FOR OVER THE COUNTER USE FOR THE T | PQY | BIOELECTRONICS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |