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

Catalog Number	004053
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Pain (1994); Skin Discoloration (2074); Swelling (2091)
Type of Reportable Event	Serious Injury
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 patient experienced pain in his shaft.He had swollen and red testicles with use of the device.The customer alleged he was seen at urgent care where he received an ultrasound and was prescribed antibiotics.The customer will follow up with the urologist to determine if he will continue use it or not.
Event or Problem Description
It was reported that the patient experienced pain in his shaft.He had swollen and red testicles with use of the device.The customer alleged he was seen at urgent care where he received an ultrasound and was prescribed antibiotics.The customer will follow up with the urologist to determine if he will continue use it or not.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause of the reported event could be inadequate biocompatibility assessment of the patient before device usage due to which it was not determined whether the materials of construction are biocompatible with the patient, resulting in patient impact and allergic reaction.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "1.A very light pressure on the urethral canal on the underside of the penis will prevent any leakage.2.The necessary pressure is achieved by the hump in the under part of the cunningham clamp.3.For proper fit and comfort the upper part of the clamp can be easily shaped by the fingers.4.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.5.Be sure that the clamp is not set so tight that it will interfere with the blood circulation.Juvenile (004052), regular (004053), large (004054) this product contains dry natural rubber.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.Washing instructions: wash with mild (hand) soap and warm water.Rinse thoroughly in cool clean water.Gently squeeze foam to discharge excess water.Let unit air dry in cool environment away from excess heat or direct sunlight.Do not use bleach, detergent, hot water, washer/dryer or blow dryer." h11:section a through f - the information provided by bd 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 bd.The device was not returned.

• Brand Name: BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP
• Common Device Name: CUNNINGHAM CLAMP
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8594620
• Report Number: 1018233-2019-02391
• Device Sequence Number: 19419489
• 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): 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 004053
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other