MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-01-12 for QUICK CHANGE CRUTCH ADULT 9153618192 8115-A manufactured by Healthplus.
[5304721]
End user's wife advised when her husband was walking in the kitchen the (b)(4) crutches wobbled and he fell. No apparent injuries, no medical attention sought.
Patient Sequence No: 1, Text Type: D, B5
[12646259]
Initial mfg report # 1531186-2014-04910 was submitted to the fda on 10/17/2014. Additional information has been obtained for the report but due to invacare's updated trackwise system a normal follow-up report could not be transmitted through normal channels. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1531186-2015-00188 |
| MDR Report Key | 4408039 |
| Report Source | * |
| Date Received | 2015-01-12 |
| Date of Report | 2014-09-25 |
| Date of Event | 2014-09-23 |
| Date Facility Aware | 2014-09-25 |
| Report Date | 2014-10-17 |
| Date Reported to FDA | 2014-10-17 |
| Date Reported to Mfgr | 2014-10-17 |
| Date Added to Maude | 2015-01-12 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICK CHANGE CRUTCH ADULT 9153618192 |
| Generic Name | TIPS AND PADS, CANE, CRUTCH AND WALKE |
| Product Code | INP |
| Date Received | 2015-01-12 |
| Model Number | 8115-A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEALTHPLUS |
| Manufacturer Address | HANDAN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-12 |