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

Catalog Number 33301

Device Problems Nonstandard Device (1420); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 the male external catheter had too strong of an adhesive.No patient injury was reported.

Manufacturer Narrative

The device was not returned for evaluation.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: ¿note: do not use on irritated or compromised skin.Do not use if allergic reaction occurs.Not made with natural rubber latex.Instruction for use in view: special 1.Preparation 2.Preparation 3.Application 4.Application 5.Removal.In view: standard 1.Application 2.Application 3.Removal".

Event Description

It was reported that the male external catheter had too strong of an adhesive.No patient injury was reported.

• Brand Name: ROCHESTER MEC ULTRAFLEX S 30BX
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8429286
• MDR Text Key: 139187596
• Report Number: 1018233-2019-01363
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2023
• Device Catalogue Number: 33301
• Device Lot Number: JUCQ0140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1