MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC ULTRAFLEX S 30BX; MALE EXTERNAL CATHETER

Model Number	33301
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: directions to apply: wash penis with mild soap and warm water.Dry thoroughly.Trim pubic hair if necessary.Unroll self-adhering catheter over penis.Gently squeeze the catheter to properly seal adhesive to the skin.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.Connect to drainage device.Directions: to remove gently roll catheter off the penis.
Event or Problem Description
It was reported that the adhesive was too strong the patient felt as though the skin was being peeled off of the penis and caused pain.No medical intervention was reported.

• Brand Name: ROCHESTER MEC ULTRAFLEX S 30BX
• Common Device Name: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8741082
• Report Number: 1018233-2019-03427
• Device Sequence Number: 2637768
• Product Code: NNX
• UDI-Device Identifier: 00801741070730
• UDI-Public: (01)00801741070730
• 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
• Report Date (Section B): 06/27/2019

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 Model Number: 33301
• Device Catalogue Number: 33301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1