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	Pain (1994); Skin Tears (2516); Patient Problem/Medical Problem (2688)
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 bought bard ¿self adhering male external catheters¿ (urinal condoms) from a diving shop, as they are often used in diving.Ref 26302, 29mm.The use of the first device was almost without problems.But the second one showed such enormous adhesive strength when it was worn for about 6 hours that it could only be removed with severe pain and skin damage in the front area [of penis].No photographic or medical evidence exists for this reason.However, with another device, the patient simulated a simulated application (5 minutes of use, room temperature) on a banana, which considered to be suitable for simulating sensitive skin.The patient attached photos of the experiment as an attachment.The patient can clearly see, the adhesive layer clearly damaged the surface of the fruit and tore out clearly visible pieces.
Event or Problem Description
It was reported that the patient bought bard ¿self adhering male external catheters¿ (urinal condoms) from a diving shop, as they are often used in diving.Ref (b)(4), 29mm.The use of the first device was almost without problems.But the second one showed such enormous adhesive strength when it was worn for about 6 hours that it could only be removed with severe pain and skin damage in the front area [of penis].No photographic or medical evidence exists for this reason.However, with another device, the patient simulated a simulated application (5 minutes of use, room temperature) on a banana, which considered to be suitable for simulating sensitive skin.The patient attached photos of the experiment as an attachment.The patient can clearly see, the adhesive layer clearly damaged the surface of the fruit and tore out clearly visible pieces.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual inspection noted 2 unopened wideband mecs were received.Visual evaluation noted no obvious defects with further testing required.The adhesive peel test was performed and samples were cut to the required width (0.70" +/- 0.05").The adhesive peel strength was found to be within specification (0.80-2.80lbf).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: "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." h11:section a through f - the information provided by bd 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 bd.

• 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: 10074237
• Report Number: 1018233-2020-03273
• Device Sequence Number: 16983694
• Product Code: NNX
• UDI-Device Identifier: 00801741071041
• UDI-Public: (01)00801741071041
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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: 01/31/2024
• Device Model Number: 36302
• Device Catalogue Number: 36302
• Device Lot Number: JUDN0172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 05/31/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1