MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-19 for BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2" 004053 manufactured by C.r. Bard, Inc. (covington) -1018233.
[103014326]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[103014327]
It was reported that the patient found the cunningham clamp instructions for use not comprehensive. The patient reportedly caught his pubic hair in the device during use and attempted to use scissors to cut his hair free. The patient cut himself with his scissors and reportedly experienced pain and self-limited bleeding. The patient would like the instructions to state that the clamp should be put on while standing and to be mindful of pubic hair. The patient stated that no medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00855 |
| MDR Report Key | 7349600 |
| Date Received | 2018-03-19 |
| Date of Report | 2018-04-06 |
| Date Mfgr Received | 2018-04-06 |
| Date Added to Maude | 2018-03-19 |
| 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 | AMY GRAVLEY |
| 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) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2" |
| Generic Name | CUNNINGHAM CLAMP |
| Product Code | FHA |
| Date Received | 2018-03-19 |
| Catalog Number | 004053 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-19 |