MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-09 for FREEDOM CATH FREEDOM COLOPLAST MALE EXTERNAL CATHETER 8200/8230 2330121 manufactured by Coloplast A/s.
[5942398]
Due to being a quadriplegic, i use the freedom cath. On (b)(4) 2014 when i got up to remove the catheter, it pulled the skin off my penis. I have undergone several surgeries already, and my doctor is now talking about removing a portion of my penis. I have already undergone two surgeries and will need a third.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043092 |
| MDR Report Key | 4847606 |
| Date Received | 2015-06-09 |
| Date of Report | 2015-06-09 |
| Date of Event | 2014-11-28 |
| Date Added to Maude | 2015-06-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM CATH FREEDOM COLOPLAST MALE EXTERNAL CATHETER |
| Generic Name | MALE EXTERNAL CATHETER, 28MM |
| Product Code | EXJ |
| Date Received | 2015-06-09 |
| Catalog Number | 8200/8230 2330121 |
| Lot Number | 4002633 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2015-06-09 |