FDA Adverse Event
Other
Summary report: N
SAFHS 2000 MOU ASSEMBLY
MDR report key: 3311016
·
Received July 25, 2013
Report
- Report Number
- 3010203571-2013-00002
- Event Type
- Other
- Date Received
- July 25, 2013
- Date of Event
- June 7, 2013
- Report Date
- July 15, 2015
- Manufacturer
- BIOVENTUS LLC
- Product Code
- LPQ
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING TREATMENT WITH THE EXOGEN DEVICE, THE PT EXPERIENCED A CASE OF ECZEMA. THE PHYSICIAN RELATES THE REACTION TO THE GEL. THIS COMPLAINT WAS REPORTED TO THE PMDA ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349521 | SAFHS 2000 MOU ASSEMBLY | BONE GROWTH STIMULATOR/LPQ | LPQ | BIOVENTUS LLC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other |