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

Model Number	36104
Medical Device Problem Codes	No Apparent Adverse Event (3189); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
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.
Event or Problem Description
It was reported that the patient was not sure about removing the male external catheter as they try to roll it down like the instructions say to, but it would not come off.Representative discussed with patient if necessary, to apply a warm wet compress, such as a wet washcloth around the catheter to help loosen the adhesive.Advised to gently roll the catheter off the penis.Patient had a box of 100 and had used about 40-50 and all of them had presented with the same issue.Also, noted that they were extremely difficult to get off the plastic lid, the sombrero.Patient stated that they did not just pop off like the instructions say.Per follow up via phone on 07may2021, customer stated that the instructions need to be more clear because it was difficult to understand how to remove the catheter from the sombrero.And also stated that the catheter was too sticky so it was difficult to remove from the patient after use.
Event or Problem Description
It was reported that the patient was not sure about removing the male external catheter as they try to roll it down like the instructions say, but it would not come off.Representative discussed with patient if necessary, to apply a warm wet compress, such as a wet washcloth around the catheter to help loosen the adhesive.Advised to gently to roll the catheter off the penis.Patient had a box of 100 and had used about 40-50 and all of them had presented with the same issue.Also, noted that they were extremely difficult to get off the plastic lid, the sombrero.Patient stated that they did not just pop off like the instructions say.Per follow up via phone on 07may2021,customer stated that the instructions need to be more clear because it was difficult to understand how to remove the catheter from the sombrero.And also stated that the catheter was too sticky so it was difficult to remove from the patient after use.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "plc failure".The lot number is unknown; therefore, the device history record could not be reviewed.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.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." the device was not returned.

• Brand Name: WIDEBAND¿ SELF-ADHERING MALE EXTERNAL CATHETER
• Common Device Name: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11909324
• Report Number: 1018233-2021-03133
• Device Sequence Number: 11015207
• Product Code: NNX
• UDI-Device Identifier: 00801741071003
• UDI-Public: (01)00801741071003
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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 Model Number: 36104
• Device Catalogue Number: 36104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 12/05/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male