MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-06-06 for FREEDOM CATH MEDIUM 5061301400 manufactured by Coloplast A/s.
[2319522]
According to the info received a user is having issues the external condom catheter tearing his foreskin. Has been using this catheter for years and has issues with this occurrence every once in a while. User has tried skin prep underneath but he tends to have redness when he uses this as well. User says he is not allergic to latex.
Patient Sequence No: 1, Text Type: D, B5
[9446314]
The product was not available to be returned. Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Should the device or add'l info be received, a f/u report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005945907-2011-00014 |
| MDR Report Key | 2367744 |
| Report Source | 04 |
| Date Received | 2011-06-06 |
| Date of Report | 2011-04-04 |
| Date of Event | 2011-04-01 |
| Date Mfgr Received | 2011-04-04 |
| Device Manufacturer Date | 2010-11-23 |
| Date Added to Maude | 2011-12-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR BRIAN SCHMIDT |
| Manufacturer Street | 1601 WEST RIVER RD, NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024987 |
| Manufacturer G1 | COLOPLAST (CHINA) CO., LTD. |
| Manufacturer Street | LOT NO.10, ZHUHAI FREE TRADE ZONE |
| Manufacturer City | ZHUHAI, GUANGDONG 519030 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 519030 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM CATH MEDIUM |
| Generic Name | MALE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 2011-06-06 |
| Model Number | 5061301400 |
| Catalog Number | 5061301400 |
| Lot Number | 2653780 |
| Device Expiration Date | 2015-05-22 |
| 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 | COLOPLAST A/S |
| Manufacturer Address | HUMLEBAEK 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-06-06 |