MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-29 for VIVE FOREARM CRUTCHES MOB1014BLK manufactured by Caremax Rehabilitation Equipment Co., Ltd..
Report Number | MW5089457 |
MDR Report Key | 8949605 |
Date Received | 2019-08-29 |
Date of Report | 2019-08-27 |
Date Added to Maude | 2019-08-30 |
Event Key | 0 |
Report Source Code | Voluntary 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 | 0 |
Brand Name | VIVE FOREARM CRUTCHES |
Generic Name | CRUTCH |
Product Code | IPR |
Date Received | 2019-08-29 |
Model Number | MOB1014BLK |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CAREMAX REHABILITATION EQUIPMENT CO., LTD. |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-08-29 |