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

Model Number 33302

Device Problems Nonstandard Device (1420); Difficult to Remove (1528)

Patient Problems Erythema (1840); Irritation (1941); Skin Discoloration (2074)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that it was difficult to remove the male external catheter from the patient's skin.The complainant reported that the catheter did not peel the skin off, but it was close and it left the area red and irritated.No medical intervention was reported.

Manufacturer Narrative

The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿too high viscosity¿ with a potential root cause of ¿viscometer failure or mechanical failure¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "directions: to remove gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.".

Event Description

It was reported that it was difficult to remove the male external catheter from the patient's skin.The complainant reported that the catheter did not peel the skin off, but it was close and it left the area red and irritated.No medical intervention was reported.

• Brand Name: ROCHESTER MEC ULTRAFLEX M 30BX
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9497238
• MDR Text Key: 178790918
• Report Number: 1018233-2019-08097
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070754
• UDI-Public: (01)00801741070754
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33302
• Device Catalogue Number: 33302
• Device Lot Number: JUDU0001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1