MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2018-08-27 for BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2" 004053 manufactured by C.r. Bard, Inc. (covington) -1018233.
[118330686]
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
[118330687]
It was reported that the patients' penis allegedly turned red and became infected while using the cunningham clamp. The patient stated he was prescribed antibiotics and was given shots at the doctors' office for the diagnosed infection. It was later reported via phone on (b)(6) 2018, the complainant stated he wore the clamp from 8am to around 5pm while he was at work. The complainant stated that he did not know what kind of infection he had or what shots or antibiotics he received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-03803 |
| MDR Report Key | 7819795 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2018-08-27 |
| Date of Report | 2018-09-25 |
| Date Mfgr Received | 2018-09-07 |
| Date Added to Maude | 2018-08-27 |
| 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 | YONIC ANDERSON |
| 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 | 3 |
| Brand Name | BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2" |
| Generic Name | CUNNINGHAM CLAMP |
| Product Code | FHA |
| Date Received | 2018-08-27 |
| 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 | 1. Required No Informationntervention | 2018-08-27 |