MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-09-30 for WIDE BAND MALE EXTERNAL CATHETER 36102 manufactured by Rochester Medical Corp..
[2232934]
The patient reported he had developed a sore on the underside of his penis from using a wide band male external catheter. The patient consulted his physician and his physician advised the patient to abstain from using the male external catheters for a week and to treat the sore with neosporin. The patient reported that he has resumed using male external catheters with no issues. We are awaiting return of samples from the customer for further evaluation. Samples from the patient's lot have been tested and were found to be within adhesive strength specifications.
Patient Sequence No: 1, Text Type: D, B5
[9305050]
Lot #: 53419077
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2130787-2011-00001 |
| MDR Report Key | 2277468 |
| Report Source | 04 |
| Date Received | 2011-09-30 |
| Date of Report | 2011-09-28 |
| Date of Event | 2011-09-26 |
| Date Mfgr Received | 2011-09-26 |
| Device Manufacturer Date | 2011-01-16 |
| Date Added to Maude | 2011-10-06 |
| 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 | 2011-09-30 |
| Model Number | 36102 |
| Lot Number | 53418403 |
| Device Expiration Date | 2016-11-01 |
| 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 | 2011-09-30 |