MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-05-11 for MCKESSON PUSH BUTTON ALUMINUM CRUTCH 14-905 manufactured by Jan Mao Industries Co. Ltd.
[5796677]
The pt's husband stated that on (b)(6) 2015 his wife had pain in her foot so they went to urgent care because their doctor's office was closed. He reported that at urgent care the pt was given crutches, told to stay off her feet, and instructed to go and see either her family doctor or foot doctor in three to five days. The husband claims that the ends of the crutches are very slippery no matter what type of floor, and that they slide out from under the pt. He asserts that the pt has fallen four times while using the crutches. The first time the crutches slipped, the pt was going into the foot doctor's office and the crutches slipped on the tile floor. The husband states the crutches went completely out from under her and she broke her good foot (not the foot she originally had an issue with). The complaint was received on 04/15/2015 via the (b)(6) hotline and forwarded to the cypress medical products complaint manager on 04/17/2015. The compliant manager confirmed with the pt's husband that the phone number used to make the initial complaint was obtained from the internet, not from the product label.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451040-2015-00003 |
| MDR Report Key | 4768818 |
| Report Source | 99 |
| Date Received | 2015-05-11 |
| Date of Report | 2015-04-15 |
| Date of Event | 2015-04-04 |
| Date Facility Aware | 2015-04-17 |
| Report Date | 2015-05-08 |
| Date Added to Maude | 2015-05-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCKESSON PUSH BUTTON ALUMINUM CRUTCH |
| Generic Name | CRUTCH |
| Product Code | IPR |
| Date Received | 2015-05-11 |
| Catalog Number | 14-905 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JAN MAO INDUSTRIES CO. LTD |
| Manufacturer Address | NO 181 CHU LIAO ROAD TA SU HSIANG KAOHSIUNG COUNTY TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-11 |