MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-30 for DISPOSABLE URINAL * NOVA20235 manufactured by Medline Industries Inc.
[5159938]
Unable to the read numbers/amount on plastic urinals. The plastic is defective, with bubbles and swiggles in the plastic where it should be smooth. As a result, staff are unable to read the amount of urine in the urinals. There are 48 devices per case. All devices in the case are affected. ======================manufacturer response for urinal, (brand not provided) (per site reporter). ======================the distributor field representative was notified of the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4180285 |
| MDR Report Key | 4180285 |
| Date Received | 2014-09-30 |
| Date of Report | 2014-09-30 |
| Date of Event | 2014-09-02 |
| Report Date | 2014-09-30 |
| Date Reported to FDA | 2014-09-30 |
| Date Reported to Mfgr | 2014-10-17 |
| Date Added to Maude | 2014-10-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE URINAL |
| Generic Name | URINAL |
| Product Code | FNP |
| Date Received | 2014-09-30 |
| Model Number | * |
| Catalog Number | NOVA20235 |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC |
| Manufacturer Address | 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-30 |