MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-05-30 for IN VIEW STANDARD MALE EXTERNAL CATHETER 97536 manufactured by Rochester Medical Corp..
[3482571]
On (b)(4) 2013, rochester medical corporation was notified that an end user of a male external catheter had difficulty in removing the catheter. The end user reported that the adhesive appeared to be too strong and injured his penis. The end user reported that he consulted a dermatologist who prescribed mupirocin ointment as treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2013-00001 |
| MDR Report Key | 3162092 |
| Report Source | 04 |
| Date Received | 2013-05-30 |
| Date of Report | 2013-05-29 |
| Date of Event | 2013-05-15 |
| Date Mfgr Received | 2013-05-29 |
| Date Added to Maude | 2013-06-12 |
| 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 DR. |
| 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 | IN VIEW STANDARD MALE EXTERNAL CATHETER |
| Generic Name | MALE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 2013-05-30 |
| Model Number | 97536 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHESTER MEDICAL CORP. |
| Manufacturer Address | STEWARTVILLE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-30 |