FDA Adverse Event
Injury
Summary report: N
VIVE FOREARM CRUTCHES
MDR report key: 8949605
·
Received August 29, 2019
Report
- Report Number
- MW5089457
- Event Type
- Injury
- Date Received
- August 29, 2019
- Report Date
- August 27, 2019
- Manufacturer
- CAREMAX REHABILITATION EQUIPMENT CO., LTD.
- Product Code
- IPR
- UDI-DI
- 00818323027198
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 1
CONSUMER LEFT A COMMENT STATING, "I GOT THESE YESTERDAY. WENT OUT TODAY AND THE ONE CRUTCHES COLLAPSED ON ME, MAKING ME FALL TO THE GROUND AND INJURING MYSELF. THE REASON I GOT THESE IS BECAUSE MY OLD ONES DID THE SAME THING. THESE WILL BE GOING BACK." FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 741849 | VIVE FOREARM CRUTCHES | CRUTCH | IPR | CAREMAX REHABILITATION EQUIPMENT CO., LTD. | MOB1014BLK | 00818323027198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |