MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-11-05 for SIMS PORTEX MALE EXTERNAL CATHETER manufactured by Rochester Medical Corp..
[704618]
End user states that he experienced a burning sensation on his penis and scrotum like a bad sunburn. End user visited doctor, and received cream for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2007-00004 |
| MDR Report Key | 938184 |
| Report Source | 08 |
| Date Received | 2007-11-05 |
| Date of Report | 2007-10-31 |
| Date of Event | 2007-10-26 |
| Date Mfgr Received | 2007-10-30 |
| Device Manufacturer Date | 2000-08-01 |
| Date Added to Maude | 2007-11-13 |
| 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 | ROB ANGLIN |
| Manufacturer Street | ONE ROCHESTER MEDICAL DRIVE |
| Manufacturer City | STEWARTVILLE MN 55976 |
| Manufacturer Country | US |
| Manufacturer Postal | 55976 |
| Manufacturer Phone | 5075339613 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMS PORTEX MALE EXTERNAL CATHETER |
| Generic Name | MALE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 2007-11-05 |
| Lot Number | 53401389 |
| Device Expiration Date | 2005-08-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 912035 |
| Manufacturer | ROCHESTER MEDICAL CORP. |
| Manufacturer Address | STEWARTVILLE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-11-05 |