MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 2

Catalog Number 37301

Device Problems Nonstandard Device (1420); Physical Resistance/Sticking (4012)

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 mec sheaths did not seem to be as sticky as before, as other mec sheaths were extremely sticky.The user had not changed soaps or washing powders.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿device is difficult to remove¿.A potential root cause for this failure could be "adhesive is too strong".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: "to remove: the sheath may be removed by gently rolling it off the penis.Avoid simply pulling the sheath off.Removing the sheath whilst having a bath or shower may increase comfort.".

Event Description

It was reported that the mec sheaths did not seem to be as sticky as before, as other mec sheaths were extremely sticky.The user had not changed soaps or washing powders.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 2
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9453081
• MDR Text Key: 178748784
• Report Number: 1018233-2019-07889
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

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: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 37301
• Device Lot Number: JUDQ0347
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1