MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-16 for MEDICHOICE 77710A 131477710A manufactured by Caremax Rehabilitation Equipment Co., Ltd.
[65361206]
(b)(4) is the initial importer and private-label distributor of the medichoice aluminum crutch, 131477710a. A product related problem was reported to an (b)(4) employee on november 14th, 2016. The (b)(4) employee reported that the patient entered the er with left knee pain on (b)(6) 2016. The patient reported that he could not put weight on his knee. He was discharged from the er with medichoice aluminum crutches. The patient stated that while he was walking to his car, he fell and twisted his knee. The crutch also broke during the incident-- it is not clear from the report whether the crutch broke, leading to the fall or whether the fall caused the crutch to break. The patient returned to the er with the broken crutch but was nor formally re-admitted. The patient stated he refused re-assessment and was provided with a new set of crutches. No new injury was reported nor was medical intervention required to prevent permanent impairment or damage to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005555653-2017-00001 |
| MDR Report Key | 6255131 |
| Date Received | 2017-01-16 |
| Date of Report | 2017-01-16 |
| Date of Event | 2017-11-12 |
| Date Mfgr Received | 2016-11-14 |
| Device Manufacturer Date | 2017-07-12 |
| Date Added to Maude | 2017-01-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | KEVIN WALLS |
| Manufacturer Street | 33 GOLDEN EAGLE LANE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7209625412 |
| Manufacturer G1 | CAREMAX REHABILITATION EQUIPMENT CO., LTD |
| Manufacturer Street | PINGNAN INDUSTRIAL AREA, SHUGA PINGZHOU TOWN, NANHAI AREA |
| Manufacturer City | FOSHAN CITY, GUANGDONG 528512 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 528512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDICHOICE |
| Generic Name | ALUMINUM CRUTCH |
| Product Code | IPR |
| Date Received | 2017-01-16 |
| Returned To Mfg | 2016-12-26 |
| Model Number | 77710A |
| Catalog Number | 131477710A |
| Lot Number | 1607CA01A |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREMAX REHABILITATION EQUIPMENT CO., LTD |
| Manufacturer Address | PINGNAN INDUSTRIAL AREA, SHUGA PINGZHOU TOWN, NANHAI AREA FOSHAN CITY, GUANGDONG 528512 CH 528512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-16 |