MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-05-03 for CRUTCH AXILLARY ADULT 62-70 300LB CA901AD manufactured by Jan Mao Industries Co., Ltd..
[44336113]
(b)(4). A review of the device history record for the lot number reported was reviewed and no indications for broken crutches were detected during the production of this lot. A review of the production and finished products inspection records for the past 12 months did not indicate any incidents of crutch tubing breakage during production. A review of the complaint history indicates this is the first reported incident for tubing breakage in the past 12 months. The production lot representative of the crutch that broke was static load tested in accordance with (b)(4) and passed. The actual crutch from this reported issue was not provided. Photos of the crutch were provided and forwarded onto the supplier. The photos did show that the crutch was broken on the bottom tube which is unusual according to the supplier. Based on the information provided for this investigation the root cause could not be determined and therefore no corrective actions will be taken at this time. We will continue to monitor for any similar reports.
Patient Sequence No: 1, Text Type: N, H10
[44336114]
The consumer reported crutch broke while he was using it, causing him to fall and bang his head, bruise his leg stump (amputee) plus multiple other bruises and scrapes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2016-00021 |
| MDR Report Key | 5628192 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-05-03 |
| Date of Report | 2016-05-03 |
| Date of Event | 2016-04-04 |
| Date Facility Aware | 2016-04-05 |
| Report Date | 2016-04-05 |
| Date Reported to Mfgr | 2016-04-05 |
| Date Mfgr Received | 2016-04-05 |
| Date Added to Maude | 2016-05-03 |
| 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 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | JAN MAO INDUSTRIES CO., LTD. |
| Manufacturer Street | GONG TING VILLAGE, FIRST INDUSTRIAL DIST.LONG XI |
| Manufacturer City | BO LUO COUNTY HUIZHOU CITY 516121 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 516121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRUTCH AXILLARY ADULT 62-70 300LB |
| Generic Name | CRUTCH AXILLARY ADULT 62-70 300LB |
| Product Code | IPR |
| Date Received | 2016-05-03 |
| Model Number | CA901AD |
| Catalog Number | CA901AD |
| Lot Number | A400001256SH |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JAN MAO INDUSTRIES CO., LTD. |
| Manufacturer Address | GONG TING VILLAGE, FIRST INDUSTRIAL DIST.LONG XI BO LUO COUNTY HUIZHOU CITY 516121 CH 516121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-03 |