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 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.
Event or Problem Description
It was reported that the rubber on the cunningham clamp was worn out and deteriorated.The patient allegedly experienced discomfort in his leg.
Additional Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.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.
Event or Problem Description
It was reported that the rubber on the cunningham clamp was worn out and deteriorated.The patient allegedly experienced discomfort in his leg.
Additional Manufacturer Narrative
A correction for field g7 was requested to capture the correct type of mdr report follow-up # that was submitted on 27-june-2018.Correction: g1, g7.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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the rubber on the cunningham clamp was worn out and deteriorated.The patient allegedly experienced discomfort in his leg.

• 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: 7591952
• Report Number: 1018233-2018-02204
• Device Sequence Number: 18886487
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 04/17/2019; 04/17/2019
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 04/18/2019; 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR