FDA Adverse Event
Injury
Summary report: N
KNEE ANKLE FOOT ORTHOSIS FULL
MDR report key: 10010778
·
Received April 29, 2020
Report
- Report Number
- 2028253-2020-00002
- Event Type
- Injury
- Date Received
- April 29, 2020
- Report Date
- April 29, 2020
- Manufacturer
- BREG, INC
- Product Code
- OHI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. A REVIEW OF INTERNAL FILES FROM DATE OF INCIDENT TO DATE IDENTIFIED NO OTHER REPORTS FOR THIS ALLEGED INCIDENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Description of Event or Problem · 1
THROUGH LEGAL NOTICE BREG, INC. RECEIVED A REPORT OF AN ALLEGED INCIDENT INVOLVING "KNEE ANKLE FOOT ORTHOSIS FULL". THE COURT DOCUMENT ALLEGES THAT IN OR ABOUT (B)(6) 2019, THE PLAINTIFF " WAS USING AFORESAID LEG BRACE, WHEN SUDDENLY, AND WITHOUT WARNING, IT BROKE, THEREBY CAUSING PLAINTIFF TO SUSTAIN SERIOUS AND PERMANENT BODILY INJURIES, WHICH REQUIRED SURGICAL REPAIR".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475415 | KNEE ANKLE FOOT ORTHOSIS FULL | KNEE ANKLE FOOT ORTHOSIS FULL | OHI | BREG, INC | MOD-L2036 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |