MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-16 for MEDICHOICE 77708A manufactured by Caremax Rehabilitation Equipment Co., Ltd..
[38286255]
Owens & minor distribution, inc. , the initial importer and private-label distributor of the medichoice crutch, received a product problem report from a user facility. The user facility reported that the wing nut on one crutch provided to one of their patients came loose on the hand grip causing the patient to fall. The fall occurred away from the user facility. The patient was examined at the hospital where they received the crutch. No injury occurred as a result of the fall, and no medical intervention was required to prevent permanent impairment or damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003753847-2016-00001 |
| MDR Report Key | 5439070 |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-16 |
| Date of Event | 2015-09-24 |
| Date Facility Aware | 2016-01-25 |
| Report Date | 2016-02-16 |
| Date Reported to FDA | 2016-02-16 |
| Date Reported to Mfgr | 2016-01-26 |
| Date Added to Maude | 2016-02-16 |
| 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 | RISK MANAGER |
| 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 | MEDICHOICE |
| Generic Name | CRUTCH |
| Product Code | IPR |
| Date Received | 2016-02-16 |
| Model Number | 77708A |
| Catalog Number | 77708A |
| Lot Number | CM1502 037576 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREMAX REHABILITATION EQUIPMENT CO., LTD. |
| Manufacturer Address | SHUGANG DADAO, PINGZHOU TOWN NANHAI AREA, FOSHAN CITY FOSHAN CITY, GUANGDONG, CHINA CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-16 |