MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-18 for BARD CUNNUNGHAM INCONTINENCE CLAMP 7816386 manufactured by C.r. Bard, Inc.
[4203235]
I got a cunnungham incontinence clamp and instructions how to use (b)(6), 2014. Told ok to wear at night so did. Somehow it got pushed against a testicle very painful. Now, still have pain when try to get up from sitting. Testicle seems swollen. Am back on just pads but incontinence seems worse then before. I feel certain the pain will go with healing but i will not use the clamp again, at least not at night. If it happens once, it can happen again. Brief report as you asked. I will discuss this with doctor next visit to this office.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034609 |
| MDR Report Key | 3639500 |
| Date Received | 2014-02-18 |
| Date of Report | 2014-02-12 |
| Date of Event | 2014-02-11 |
| Date Added to Maude | 2014-02-24 |
| 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 | BARD CUNNUNGHAM INCONTINENCE CLAMP |
| Generic Name | BARD CUNNUNGHAM INCONTINENCE CLAMP |
| Product Code | FHA |
| Date Received | 2014-02-18 |
| Model Number | 7816386 |
| Lot Number | +H3020040530W |
| ID Number | PC-2335 3/2000 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC |
| Manufacturer Address | COVINGTON GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-18 |