MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NATURAL¿ NON-ADHESIVE MALE EXTERNAL CATHETER; MEC

Model Number	38303
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.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: "non-adhesive, all-silicone male external catheter with strap.Description/indication- the natural¿ catheter is a non-adhesive, all-silicone male external catheter designed for the management of male urinary incontinence.Contraindication- do not use on irritated or compromised skin.Precautions- do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for periods longer than 24 hours may increase the risk of complications.Applying strap tightly may cause injury to the penis from decreased circulation.Keep strap clean and dry.Directions: to apply catheter 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) unroll catheter over penis.4) gently wrap strap over catheter around penis and secure with hook and loop closure.Ensure strap remains over catheter sheath.(to maintain hook and loop closure function, keep hook and loop closed when strap is not in use.) important: to avoid injury, do not overtighten strap.5) connect to drainage device.To remove catheter 1) remove strap by separating hook and loop closure.2) gently roll catheter off the penis." the device was not returned.
Event or Problem Description
It was reported that the male external catheter adhesive was strong.The patient allegedly experienced difficulty getting the adhesive off of his skin.No medical intervention reported.

• Brand Name: NATURAL¿ NON-ADHESIVE 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: 7970087
• Report Number: 1018233-2018-04784
• Device Sequence Number: 202110
• Product Code: NNX
• UDI-Device Identifier: 00801741071249
• UDI-Public: (01)00801741071249
• 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
• Report Date (Section B): 10/16/2018

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: 38303
• Device Catalogue Number: 38303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1