MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-01-12 for H140D-01 manufactured by Medegen Medical Products.
[1794698]
It was reported that sharp edge of a urinal cut a pt. No further information on the pts condition has been made available.
Patient Sequence No: 1, Text Type: D, B5
[8942751]
The complaint was rec'd from (b)(4) territory mgr at the complaint unit for medegen medical products on (b)(4) 2010 and was immediately assigned complaint (b)(4). (b)(6) was contacted for more information and to retrieve the complained urinal. Investigation: no further information was given on the condition of the pt and the lot number was unk. The complained urinal was visually inspected and the rubber glove test as administered per specification number (b)(4). The glove test consisted of: rubbing gloved hand around and across the outside/inside urinal checking for sharp edges and protrusions that may puncture a surgical glove. The glove used on the complained urinal showed no tears, snags or drag marks. Conclusion: there were no protrusions or sharp edges found on the complained urinal and we are unable to ascertain how the urinal cut the pt without further pt information. Quality assurance will continue to perform visual inspections/(b)(4) once every hour per shift per specification number (b)(4), and will continue to monitor for this defect and address individual complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043646-2010-00002 |
| MDR Report Key | 1961735 |
| Report Source | 06 |
| Date Received | 2011-01-12 |
| Date of Report | 2011-01-12 |
| Date of Event | 2010-12-05 |
| Date Mfgr Received | 2010-12-17 |
| Date Added to Maude | 2011-04-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY FARBER, SPECIALIST |
| Manufacturer Street | 9000 WESTMONT DRIVE |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal | 23168 |
| Manufacturer Phone | 7575663510 |
| Manufacturer G1 | MEDEGEN MEDICAL PRODUCTS, A MEDICAL ACTION COMPANY |
| Manufacturer Street | 209 MEDEGEN DRIVE |
| Manufacturer City | GALLAWAY TN 38036 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | URINAL |
| Product Code | FNP |
| Date Received | 2011-01-12 |
| Returned To Mfg | 2010-01-03 |
| Model Number | H140D-01 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDEGEN MEDICAL PRODUCTS |
| Manufacturer Address | GALLAWAY TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-01-12 |