MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-07 for SUNMARK FOREARM CRUTCH ADULT 194-9171 manufactured by Jan Mao Industries Co., Ltd..
[56819899]
On 09/13/2016, a complaint was received from an employee of (b)(6) drug store who claimed that a customer returned to the drug store on (b)(6) 2016 with a pair of forearm crutches, one of which was broken in half. Based on the pictures sent to us by the complainant, it appears that the crutch is broken at the upper most pre-drilled hole used for the push button adjustment. The complainant reported that the crutches were purchased from (b)(6) in (b)(6) 2016. The complainant also stated that the customer alleged that he fell, although no injury occurred. We followed up with the complainant on 09/27/2016 in order to collect information for this report. The complainant indicated that the crutches in question were purchased from (b)(6) on (b)(6) 2016. We followed up with the manufacturer on 09/27/2016 and based on the serial number of the crutches in question, the manufacturer advised that the crutches were manufactured 01/13/2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451040-2016-00001 |
| MDR Report Key | 6011786 |
| Date Received | 2016-10-07 |
| Date of Report | 2016-10-07 |
| Date of Event | 2016-09-12 |
| Date Facility Aware | 2016-09-13 |
| Date Added to Maude | 2016-10-07 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNMARK FOREARM CRUTCH ADULT |
| Generic Name | FOREARM CRUTCH |
| Product Code | IPR |
| Date Received | 2016-10-07 |
| Catalog Number | 194-9171 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 8 MO |
| 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 840 TW 840 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-07 |