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

Model Number	36302
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Pain (1994); Skin Irritation (2076)
Date of Event	12/07/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the patient had difficulties removing the wideband condom catheter, allegedly due to strong adhesive.He was able to remove the catheter using zwitsal, baby oil, bandage, scissors, and tweezers.The patient allegedly experienced pain, skin irritation, and two bruises on the foreskin upon removal of the catheter. the patient reported he properly washed his penis according to the instructions, removed hairs, and applied the condom, with the characteristics of the wideband.
Event or Problem Description
It was reported that the patient had difficulties removing the wideband condom catheter, allegedly due to strong adhesive.He was able to remove the catheter using zwitsal, baby oil, bandage, scissors, and tweezers.The patient allegedly experienced pain, skin irritation, and two bruises on the foreskin upon removal of the catheter. the patient reported he properly washed his penis according to the instructions, removed hairs, and applied the condom, with the characteristics of the wideband.
Additional Manufacturer Narrative
The reported event was inconclusive.Visual evaluation noted the photo sample was of poor sample quality.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: ¿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.4) to remove plastic insert, squeeze catheter at the top of the white cone and pull to release.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." correction:concomitant medical products and device evaluated by mfr.

• Brand Name: WIDEBAND¿ SELF-ADHERING MALE EXTERNAL CATHETER
• Common Device Name: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8210089
• Report Number: 1018233-2019-00025
• Device Sequence Number: 2640080
• Product Code: NNX
• UDI-Device Identifier: 00801741071041
• UDI-Public: (01)00801741071041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Model Number: 36302
• Device Catalogue Number: 36302
• Device Lot Number: NGZH1048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1