MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-10-20 for WIDE BAND MALE EXTERNAL CATHETER 36302 manufactured by Rochester Medical Corp..
[2342430]
The patient had used five of the wide band male external catheters and had developed redness and soreness. The patient called a doctor and the doctor advised the patient to quit using the male external catheters and prescribed a powder to use to clear up the skin. The patient has continued use of the wide band male external catheter and has had no reactions. The patient stated he had not changed his application process, soaps or diet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2011-00003 |
| MDR Report Key | 2310009 |
| Report Source | 07 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-10-19 |
| Date of Event | 2011-10-18 |
| Date Mfgr Received | 2011-10-14 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-07-11 |
| 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 | WIDE BAND MALE EXTERNAL CATHETER |
| Generic Name | MALE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 2011-10-20 |
| Model Number | 36302 |
| Lot Number | 53419077 |
| Device Expiration Date | 2016-07-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 | 2011-10-20 |