MAUDE Adverse Event Report: ULTRAFLEX¿ SELF-ADHERING MALE EXTERNAL CATHETER; MEC

Model Number	33302
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	Pain (1994); No Consequences Or Impact To Patient (2199)
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 catheters were painful to remove from the patient and should come with instructions to trim the area.
Additional Manufacturer Narrative
The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿too high viscosity¿ with a potential root cause of ¿viscometer failure or mechanical 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: "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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the catheters were painful to remove from the patient and should come with instructions to trim the area.

• Brand Name: ULTRAFLEX¿ SELF-ADHERING MALE EXTERNAL CATHETER
• Common Device Name: MEC
• MDR Report Key: 10018249
• Report Number: 1018233-2020-02971
• Device Sequence Number: 11614405
• Product Code: NNX
• UDI-Device Identifier: 00801741070754
• UDI-Public: (01)00801741070754
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2020

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 Model Number: 33302
• Device Catalogue Number: 33302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1