MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 32MM 100BX; MALE EXTERNAL CATHETER

Model Number 37103

Device Problems Nonstandard Device (1420); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.

Event Description

It was reported that the adhesive on the male external catheter was too strong, and made it difficult to remove.

Event Description

It was reported that the adhesive on the male external catheter was too strong, and made it difficult to remove.

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 state the following: "pop-on¿ self-adhering male external catheter wideband¿.Self-adhering male external catheter spirit® style 2 / style 3.Hydrocolloid adhesive sheath en description/indication.The self-adhering male external catheter is designed for the management of male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Precaution: do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply: 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) open package at perforation.4) to remove plastic insert, squeeze catheter at the top of the white cone and pull to release.5) unroll self-adhering catheter over penis.6) gently squeeze the catheter to properly seal adhesive to the skin.7) connect to collection bag.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.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.Catalog number lot number caution: consult accompanying documents use by units manufacturer authorized representative not made with natural rubber latex non-sterile manufacturer: (b)(4).The device was not returned.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 32MM 100BX
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7372778
• MDR Text Key: 103798259
• Report Number: 1018233-2018-00956
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071140
• UDI-Public: (01)00801741071140
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2022
• Device Model Number: 37103
• Device Catalogue Number: 37103
• Device Lot Number: JUBZ0286
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR