MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-06 for NOVAPLUS NOVA20235 manufactured by Medline Industries Inc..
[99103942]
Patient Sequence No: 1, Text Type: N, H10
[99103943]
Sharp edge on new plastic urinal caused skin injury. Manufacturer response for plastic disposable urinal, novaplus (per site reporter): pending response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7243802 |
| MDR Report Key | 7243802 |
| Date Received | 2018-02-06 |
| Date of Report | 2018-01-24 |
| Date of Event | 2018-01-06 |
| Report Date | 2018-01-24 |
| Date Reported to FDA | 2018-01-24 |
| Date Reported to Mfgr | 2018-01-24 |
| Date Added to Maude | 2018-02-06 |
| 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 |
| 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 | NOVAPLUS |
| Generic Name | URINAL |
| Product Code | FNP |
| Date Received | 2018-02-06 |
| Model Number | NOVA20235 |
| Catalog Number | NOVA20235 |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | 1204 TOWNLINE ROAD 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-06 |