MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-08 for DK DS KNEE WRAP W/2 11-0913-0-02000 manufactured by Djo, Llc.
[138214262]
The nurse was discharging a total joint patient from hospital. A durasoft gel pack was to be sent home with patient. When nurse opened package to teach patient how to use gel pack, the nurse noticed there was mold growing on the educational insert paper inside with the gel pack. The plastic container appeared to be moist on the inside as well. Nurse reported contaminated material to nurse manager.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8403159 |
| MDR Report Key | 8403159 |
| Date Received | 2019-03-08 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-02-26 |
| Report Date | 2019-02-27 |
| Date Reported to FDA | 2019-02-27 |
| Date Reported to Mfgr | 2019-03-08 |
| Date Added to Maude | 2019-03-08 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | DK DS KNEE WRAP W/2 |
| Generic Name | WRAP, KNEE |
| Product Code | ISY |
| Date Received | 2019-03-08 |
| Catalog Number | 11-0913-0-02000 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-08 |