MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-08-14 for SPIRIT MALE EXTERNAL CATHETER 39301 manufactured by Rochester Medical Corp..
[19726777]
On (b)(6) 2013, rochester medical corporation was contacted by an end user of a self adhering male external catheter who stated that he developed a sore on his penis. The end user stated that he consulted his physician about the sore. The physician prescribed a duoderm hydrocolloid patch to cover the sore. The end user states that he then can continue use of the male external catheter over the patch. The end user states that the sore clears up with use of the hydrocolloid patch. The end user continued use of the male external catheter without the hydrocolloid patch and the sore returns. The end user also stated that he uses a skin prep adhesive with the male external catheter as well as external tape to keep the catheter in place. The end user stated that he has done this with all of his male external catheters over the last 10+ years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2013-00002 |
| MDR Report Key | 3299438 |
| Report Source | 04 |
| Date Received | 2013-08-14 |
| Date of Report | 2013-08-13 |
| Date Mfgr Received | 2013-08-13 |
| Date Added to Maude | 2013-08-22 |
| 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 | SPIRIT MALE EXTERNAL CATHETER |
| Generic Name | MALE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 2013-08-14 |
| Model Number | 39301 |
| Lot Number | UNK |
| 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 | 2013-08-14 |