MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2"; CUNNINGHAM CLAMP

Catalog Number	004053
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the that box did not have clear instructions on how to use the clamp.The patient experienced some discomfort after one hour of use.No medical intervention was reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: a very light pressure on the urethral canal on the underside of the penis will prevent any leakage.The necessary pressure is achieved by the hump in the under part of the cunningham clamp.For proper fit and comfort the upper part of the clamp can be easily shaped by the fingers.Exact adjustment of pressure is achieved by the ratchet catch on the regular and large sizes and the adjustable snap button on the juvenile size.To release the catch on the regular and large sizes, merely press inward on both the spring wire loops.Be sure that the clamp is not set so tight that it will interfere with the blood circulation.For the effective control of enuresis (bed wetting) in males of all ages.After repeated usage and proper maintenance (see washing instructions), inspect the product for signs of deterioration or damage (cracking, discoloration, separation of foam).The clamp should be replaced every 3 months, or sooner if the foam deteriorates." the device was not returned.
Event or Problem Description
It was reported that the that box did not have clear instructions on how to use the clamp.The patient experienced some discomfort after one hour of use.No medical intervention was reported.

• Brand Name: BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2"
• Common Device Name: CUNNINGHAM CLAMP
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8119894
• Report Number: 1018233-2018-05722
• Device Sequence Number: 13510173
• Product Code: FHA
• UDI-Device Identifier: 00801741072758
• UDI-Public: (01)00801741072758
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 004053
• Device Lot Number: BMCRGS01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1