MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-26 for URINAL H140-01 manufactured by Medegen Medical Products.
[112306700]
Patient stated he needed to use restroom in therapy gym. Patient was taken to room in wheelchair with daughter present. Daughter unties patient's pants, stating patient needs to use bathroom now. Daughter was assisting therapist with urinal placement. Therapist places penis into urinal but it slips out. Attempted to place penis back into urinal, patient states "ow". Urinal pulled back with spots of blood visible on front of depends. Nursing called into room. No visible cuts on outside of penis. Nursing contacted resident. Manufacturer: (b)(4), lot #236064. Manufacturer response for urinal, (brand not provided) (per site reporter). To assess/feel the urinal for any sharp edges prior to patient use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7637324 |
| MDR Report Key | 7637324 |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-14 |
| Date of Event | 2018-05-01 |
| Report Date | 2018-06-14 |
| Date Reported to FDA | 2018-06-14 |
| Date Reported to Mfgr | 2018-06-26 |
| Date Added to Maude | 2018-06-26 |
| 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 | URINAL |
| Generic Name | URINAL |
| Product Code | FNP |
| Date Received | 2018-06-26 |
| Model Number | H140-01 |
| Catalog Number | H140-01 |
| Lot Number | 236064 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDEGEN MEDICAL PRODUCTS |
| Manufacturer Address | 209 MEDEGEN DRIVE GALLAWAY TN 38036 US 38036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-26 |