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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 WIDEBAND SELF-ADHERING MALE EXTERNAL CATHETER; MEC

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C.R. BARD, INC. (COVINGTON) -1018233 WIDEBAND SELF-ADHERING MALE EXTERNAL CATHETER; MEC Back to Search Results
Model Number 36105
Device Problems Nonstandard Device (1420); Output above Specifications (1432)
Patient Problems No Patient Involvement (2645); 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 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.
 
Event Description
It was reported that, during an investigation, the investigator found that three male external catheters were above specification for strong adhesive.
 
Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.Visual inspection noted no obvious defects.The samples evaluated were found above specification in the peel strength test.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿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." section a through f - 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.
 
Event Description
It was reported that, during an investigation, the investigator found that three male external catheters were above specification for strong adhesive.
 
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Brand Name
WIDEBAND SELF-ADHERING MALE EXTERNAL CATHETER
Type of Device
MEC
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7753518
MDR Text Key116426005
Report Number1018233-2018-03388
Device Sequence Number0
Product Code NNX
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/28/2022
Device Model Number36105
Device Catalogue Number36105
Device Lot NumberJUBP0322
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2018
Initial Date Manufacturer Received 07/18/2018
Initial Date FDA Received08/06/2018
Supplement Dates Manufacturer Received08/15/2018
Supplement Dates FDA Received08/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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