MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-05 for CRUTCHES ALUMINUM PUSH BUTTON 100309-000 manufactured by Caremax Rehabilitation Equipment Co., Ltd..
[110585483]
Patient was being escorted to his car when the left crutch bent and caused him to fall to the ground. Patient now complains of some left shoulder pain. Patient is able to move the left shoulder. Physical exam - no bruising or swelling. Full left shoulder rom and strength. Compartment soft with 2+radial pulses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005555653-2018-00001 |
| MDR Report Key | 7568931 |
| Date Received | 2018-06-05 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-04-15 |
| Date Mfgr Received | 2018-05-29 |
| Date Added to Maude | 2018-06-05 |
| 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, SHUGANG DADAO, PINGZHOU TOWN, |
| Manufacturer City | NANHAI AREA, FOSHAN CITY, GUANGDONG 528251 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 528251 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRUTCHES ALUMINUM PUSH BUTTON |
| Generic Name | CRUTCH |
| Product Code | IPR |
| Date Received | 2018-06-05 |
| Model Number | 100309-000 |
| Catalog Number | 100309-000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREMAX REHABILITATION EQUIPMENT CO., LTD. |
| Manufacturer Address | PINGNAN INDUSTRIAL AREA, SHUGANG DADAO, PINGZHOU TOWN, NANHAI AREA, FOSHAN CITY, GUANGDONG 528251 CH 528251 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-05 |