MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-13 for NOVAPLUS NOVA20235 manufactured by Medline Industries, Inc..
[67270612]
Patient Sequence No: 1, Text Type: N, H10
[67270613]
Sharp edge on new plastic urinal caused skin injury to two patients on two separate occasions. Manufacturer response for plastic disposal urinal, novaplus (per site reporter): original advice was to return items of concern to them for replacement, which the hospital materials management department at the hospital did. However, we were advised that #275-4 reflects that this urinal was manufactured by a specific machine. We were also advised that we would continue to receive urinals manufactured by this machine in the future. We were also advised that the shipping box would contain urinals manufactured by multiple machines and assigned a lot number on the outer box. The hospital is stocked with individual urinals that do not reflect the lot number on the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6325507 |
| MDR Report Key | 6325507 |
| Date Received | 2017-02-13 |
| Date of Report | 2017-01-23 |
| Date of Event | 2017-01-16 |
| Report Date | 2017-01-23 |
| Date Reported to FDA | 2017-01-23 |
| Date Reported to Mfgr | 2017-01-23 |
| Date Added to Maude | 2017-02-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | PLASTIC DISPOSAL URINAL |
| Product Code | FNP |
| Date Received | 2017-02-13 |
| Returned To Mfg | 2017-01-20 |
| Model Number | NOVA20235 |
| Catalog Number | NOVA20235 |
| Lot Number | N/A |
| ID Number | N/A |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1200 TOWNLINE ROAD MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-13 |