MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-02-20 for MECWIDEBAND 36302 manufactured by Rochester Med. Corp..
[5505362]
It was reported that as a result of using the catheter the patient's penis became inflamed and swollen and he developed a fungus. The patient had to have an indwelling catheter placed and a topical prescription cream in order to treat the reaction. The patient feels that the adhesive on the male external catheter caused the reaction. Per additional information from the patient on (b)(6) 2015, the patient has used this product for 30 years and has never had a reaction to it until now.
Patient Sequence No: 1, Text Type: D, B5
[12843847]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2015-00051 |
| MDR Report Key | 4539148 |
| Report Source | 04 |
| Date Received | 2015-02-20 |
| Date of Report | 2015-01-28 |
| Date Mfgr Received | 2015-01-28 |
| Date Added to Maude | 2015-02-25 |
| 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 | CHRISTY LEWIS |
| Manufacturer Street | 8195 INDUSTRIAL BLVD. |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | ROCHESTER MEDICAL CORP. |
| Manufacturer Street | ONE ROCHESTER MED. DR. |
| Manufacturer City | COVINGTON GA 5597 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 5597 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MECWIDEBAND |
| Product Code | EXJ |
| Date Received | 2015-02-20 |
| Returned To Mfg | 2015-02-13 |
| Model Number | NA |
| Catalog Number | 36302 |
| Lot Number | 53426915 |
| ID Number | NA |
| Device Expiration Date | 2019-07-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHESTER MED. CORP. |
| Manufacturer Address | STEWARTVILLE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-20 |