MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-26 for BARD CUNNIHGHAM MALE INCONTINENCE PENILE CLAMP 004053 manufactured by C.r. Bard, Inc. (covington).
[21806734]
Complaint # (b)(4). It was reported that the pt was comfortable using the clamp initially. The clamp is only used for a couple of hours in the evening. As use of the clamp continued, the pt developed discomfort leading to f/u visits with the urologist. Pt has been cultured twice in 10 days, both came back negative for infections. A scope was done and the doctor informed the pt that there is a dark sport on the urethra that appears to be in the area where the clamp would be positioned. Pt underwent prostate surgery in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[21908958]
The investigation is still in progress. Upon completion of the investigation, a supplemental f/u report will be mailed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2013-02998 |
| MDR Report Key | 3255577 |
| Report Source | 05,06 |
| Date Received | 2013-07-26 |
| Date of Report | 2013-06-28 |
| Date Mfgr Received | 2013-06-28 |
| Date Added to Maude | 2013-08-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KIM SHIRAH |
| Manufacturer Street | 8195 INDUSTRIAL BLVD. |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) |
| Manufacturer Street | 8195 INDUSTRIAL BLVD. |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD CUNNIHGHAM MALE INCONTINENCE PENILE CLAMP |
| Product Code | FHA |
| Date Received | 2013-07-26 |
| Model Number | NA |
| Catalog Number | 004053 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) |
| Manufacturer Address | COVINGTON GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-26 |