MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-12 for UROCLAMP manufactured by Unk.
[85960382]
My father has been using different incontinence clamps since his cancer prostate surgery back in 2014, he has used several brands and types of clamps (cunningham, dribblestop, wiesner and others), last month i ordered him a new clamp available on (b)(6) called uroclamp, after a few days he began bleeding when urinating. I tried to contact the company to evaluate this eval but found no contact point, i even researched the fda registered mfrs found that this device is being sold illegally in the us as they have no fda registration or listing. Please evaluate this offering as the product has several quality problems when compared to other incontinence clamps this can lead to problems just like my father's or worse. There is no registered mfr, distributor or importer for this device and this is illegal. Best regards. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072106 |
| MDR Report Key | 6857692 |
| Date Received | 2017-09-12 |
| Date of Report | 2017-09-08 |
| Date of Event | 2017-08-23 |
| Date Added to Maude | 2017-09-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UROCLAMP |
| Generic Name | UROCLAMP |
| Product Code | FHA |
| Date Received | 2017-09-12 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-12 |