MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-21 for DRIVE MEDICAL HX5 9JP 10430-1 manufactured by Drive Medical.
[4962074]
Incident description: my daughter injured her elbow when her www. Drivemedical. Com crutches collapsed. The cheap plastic piece on the hand bar collapsed. School nurse tried to paper tape them back together. She is only (b)(6) (weight limit is 300 pounds), using them cautiously, but the pin holding them at the proper adjustment keeps slipping out randomly as she uses the crutches. (b)(6) is refusing to pick them up and unsure of how to get credit or replace with (b)(6). There is no "contact us" on the website. Totally cheap, unsafe design. Please file a complaint and safety report with the mfr. Incident location: school. Injury info: injury, seen by med professional. Retailer: (b)(6). Purchase date: (b)(6) 2014. Explanation: can't, no "contact us" on website. (b)(4). Report submitted date: 10/14/2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038784 |
| MDR Report Key | 4199249 |
| Date Received | 2014-10-21 |
| Date of Report | 2014-10-14 |
| Date Added to Maude | 2014-10-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE MEDICAL HX5 9JP |
| Generic Name | CRUTCHES |
| Product Code | IPR |
| Date Received | 2014-10-21 |
| Model Number | 10430-1 |
| Catalog Number | 10430-1 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRIVE MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-21 |