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

Model Number	004053
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cunningham clamp rubbed a spot onto the patient.No medical intervention was reported.Per follow up received on 11apr2022, it was stated that the cunningham clamp rubbed a sore on the shaft.It was stated that there wound was there for 3 weeks.This was the second time that this had happened.Doctor prescribed medication for the wound and advised customer to pad the patient penis with gauze to help with chafing.Customer was also sent a larger size with the same results.
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.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "material defect or incorrect material specification".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: ¿direction for easy adjustment to give proper fit and comfort 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.¿ h11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the cunningham clamp rubbed a spot onto the patient.No medical intervention was reported.Per follow up received on 11apr2022, it was stated that the cunningham clamp rubbed a sore on the shaft.It was stated that there wound was there for 3 weeks.This was the second time that this had happened.Doctor prescribed medication for the wound and advised customer to pad the patient penis with gauze to help with chafing.Customer was also sent a larger size with the same results.

• Brand Name: INCONTINENCE CLAMP
• Common Device Name: CUNNINGHAM CLAMP
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14310738
• Report Number: 1018233-2022-03390
• Device Sequence Number: 12083488
• Product Code: FHA
• UDI-Device Identifier: 00801741072765
• UDI-Public: (01)00801741072765
• 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: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 004053
• Device Catalogue Number: 004054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male