MAUDE Adverse Event Report: COVIDIEN FOLY CATH 100 SLCON 3CC 10FR; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	8887603101
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Pain (1994); Blood Loss (2597)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed, and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that when the balloon was inserted and inflated, the patient experienced intense pain after half an hour and slight bleeding in the penis.When the catheter was removed, it was impossible to deflate the balloon.After several attempts, the balloon was removed, but did not deflate evenly with difficulty in deflating the balloon to remove the injected saline.Consequences to the patient included bleeding, pain, and transfer to necker emergency room.

• Brand Name: FOLY CATH 100 SLCON 3CC 10FR
• Common Device Name: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 10878480
• Report Number: 9611018-2020-00465
• Device Sequence Number: 19540255
• Product Code: FCM
• UDI-Device Identifier: 10884521016620
• UDI-Public: 10884521016620
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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: No Information
• Device Model Number: 8887603101
• Device Catalogue Number: 8887603101
• Device Lot Number: 20E027FHX
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/20/2020
• Patient Sequence Number: 1