BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2" 004053

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-04-12 for BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2" 004053 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[141805315] The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10

[141805316] It was reported that the cunningham clamp was larger than 2 inches.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1018233-2019-01933
• MDR Report Key: 8509362
• Report Source: CONSUMER,OTHER
• Date Received: 2019-04-12
• Date of Report: 2019-04-25
• Date Mfgr Received: 2019-04-24
• Date Added to Maude: 2019-04-12
• 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

Device Details

• Brand Name: BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2"
• Generic Name: CUNNINGHAM CLAMP
• Product Code: FHA
• Date Received: 2019-04-12
• Returned To Mfg: 2019-04-09
• Catalog Number: 004053
• Lot Number: BMCYGS04
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: *
• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-04-12