MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-14 for PROCARE POST OP SHOE 79-81147 E-416197 manufactured by Djo Global Company.
[77864583]
Patient presented to medical office with broken post op shoe. The velcro just fell apart on her. Rn got patient another shoe and the same issue happened with the brand new one.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070447 |
| MDR Report Key | 6646882 |
| Date Received | 2017-06-14 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-06-01 |
| Date Added to Maude | 2017-06-16 |
| 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 |
| Reporter Occupation | UNKNOWN |
| 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 | PROCARE POST OP SHOE |
| Generic Name | MED/SURG SHOE - SIZE L ORTHOSIS, CORRECTIVE SHOE |
| Product Code | IPG |
| Date Received | 2017-06-14 |
| Model Number | 79-81147 |
| Catalog Number | E-416197 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO GLOBAL COMPANY |
| Manufacturer Address | VISTA CA 92081 US 92081 |
| Brand Name | PROCARE POST OP SHOE |
| Generic Name | MED/SURG SHOE - SIZE L ORTHOSIS, CORRECTIVE SHOE |
| Product Code | IPG |
| Date Received | 2017-06-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | DJO GLOBAL COMPANY |
| Manufacturer Address | VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-14 |