MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 32MM 30BX

Catalog Number 35303

Device Problems Nonstandard Device (1420); Sticking (1597); No Flow (2991)

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

Event Date 05/16/2018

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 mec was too sticky and the sheath did not unroll.The patient alleged there was too much adhesive.The adhesive blocked his penis, and he was unable to urinate into the sheath.When he finally was able to urinate an endless stream came out of him and he allegedly experienced pain and discomfort.

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: "transfix all silicone self-adhesive continence sheath instructions for use description/indication the transfixtm all silicone self-adhesive continence sheath is designed for the management of male urinary incontinence.It is available in five sizes ranging from small (25mm) to extra large (41mm).Contraindication do not use on irritated or compromised skin.Precaution ¿ do not use if allergic reaction occurs.¿ for good hygiene, change sheath 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 remove sheath from plastic insert (styles 2 & 3).4 place sheath funnel over penile tip.5 squeeze the funnel to seal sheath to penile tip.6 gently pull sheath to expose penile shaft.7 unroll sheath over penis.8 gently squeeze the sheath to properly seal adhesive to the skin.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.9 connect to drainage device.Directions: to remove gently roll sheath off the penis.Bard and transfix are trademarks and/or registered trademarks of c.R.Bard, inc.©2016 c.R.Bard, inc.All rights reserved.".

Event Description

It was reported that the mec was too sticky and the sheath did not unroll.The patient alleged there was too much adhesive.The adhesive blocked his penis, and he was unable to urinate into the sheath.When he finally was able to urinate an endless stream came out of him and he allegedly experienced pain and discomfort.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 32MM 30BX
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7567121
• MDR Text Key: 110177819
• Report Number: 1018233-2018-02034
• 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: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2022
• Device Catalogue Number: 35303
• Device Lot Number: JUBV0729
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1