MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-18 for FREEDOM CATH MEDIUM 5061301400 manufactured by Coloplast A/s.
[23388183]
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 additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[23388184]
According to the information received, via medwatch mw5043092, in 2014, when customer got up to remove the catheter, it pulled the skin off his penis. He has undergone several surgeries already, and doctor is now talking about removing a portion of the penis. Customer has already undergone two surgeries and will need a third. Customer stated that he had been using mec's for about 14 years prior to this incident. He mainly used them at night. He mentioned one morning back in (b)(6) 2014 he went to unroll the mec from his penis and all the "skin and meat" was removed with the mec. The doctors have tried to replace the skin from other parts of his body but it hasn't been very successful. He doesn't use mec's right now. When asked if it was a coloplast mec that was the direct cause, he said yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005945907-2015-00001 |
| MDR Report Key | 5011897 |
| Date Received | 2015-08-18 |
| Date of Report | 2015-08-17 |
| Date of Event | 2014-11-28 |
| Date Mfgr Received | 2015-07-21 |
| Device Manufacturer Date | 2014-01-24 |
| Date Added to Maude | 2015-08-18 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BRIANNA MACDONALD |
| Manufacturer Street | 1601 W RIVER RD N |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123377800 |
| Manufacturer G1 | COLOPLAST A/S ZHUHAI |
| Manufacturer Street | BAO GHENG RD |
| Manufacturer City | ZHUHAI, GUANGDONG 519090 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 519090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FREEDOM CATH MEDIUM |
| Generic Name | DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE |
| Product Code | EXJ |
| Date Received | 2015-08-18 |
| Model Number | 5061301400 |
| Catalog Number | 5061301400 |
| Lot Number | 4002633 |
| Device Expiration Date | 2018-07-19 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM 1 HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-18 |