MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-23 for VOLLRATH H140D-01 UNK manufactured by Medegen Medical Products.
[37528691]
Based upon our review of our complaint histories and manufacturing data, this is an isolated incident. Although the specific area suspected to have caused the cut was not identified, we inspected the urinal in all areas of potential bodily contact of the returned unit reported and additional units supplied. A parting line where two mold halves come together is located on the inner surface of the urinal. Through tactile and visual inspection we could not identify and sharp edges. Using lightweight latex gloves as simulated skin, we could not snag, create a cut, or abrade the glove contacting the urinal surface. There exist the potential for the user to apply enough upward force to tear the sensitive skin at the noted body area through pressure against the body unrelated to the surface characteristic of the urinal. Although we can not verify this experience report, we have added additional inspection criteria to monitor this inner surface during our normal inspection process.
Patient Sequence No: 1, Text Type: N, H10
[37528694]
Patient's wife told the nursing staff that when he used the urinal, it cut him. Bloody drainage noted at base of penis and foreskin areas. Cold packs applied immediately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043646-2003-00001 |
| MDR Report Key | 5404988 |
| Date Received | 2004-01-23 |
| Date of Report | 2003-11-17 |
| Date of Event | 2003-11-12 |
| Date Facility Aware | 2003-11-11 |
| Report Date | 2003-11-17 |
| Date Reported to FDA | 2003-11-20 |
| Date Reported to Mfgr | 2003-11-20 |
| Date Mfgr Received | 2003-12-23 |
| Date Added to Maude | 2016-02-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | SHIRLEY DAVIS |
| Manufacturer Street | 209 MEDEGEN DR. |
| Manufacturer City | GALLAWAY TN 38036 |
| Manufacturer Country | US |
| Manufacturer Postal | 38036 |
| Manufacturer Phone | 9018672951 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VOLLRATH |
| Generic Name | MALE URINAL |
| Product Code | FNP |
| Date Received | 2004-01-23 |
| Model Number | H140D-01 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDEGEN MEDICAL PRODUCTS |
| Manufacturer Address | 209 MEDEGEN DR. GALLAWAY TN 38036 US 38036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-01-23 |