MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC NATURAL M 30BX

Model Number	38302
Health Effect - Clinical Code	Cyanosis (1798)
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 information provided by bard 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 bard.The device was not returned.
Event or Problem Description
It was reported that the catheter had too strong of an adhesive.The catheter left a blue ring around the patient's penis.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use 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." (b)(4).
Event or Problem Description
It was reported that the catheter had too strong of an adhesive.The catheter left a blue ring around the patient's penis.

• Brand Name: ROCHESTER MEC NATURAL M 30BX
• Common Device Name: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7287824
• Report Number: 1018233-2018-00498
• Device Sequence Number: 16719472
• Product Code: NNX
• UDI-Device Identifier: 00801741071232
• UDI-Public: (01)00801741071232
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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 Expiration Date: 02/28/2022
• Device Model Number: 38302
• Device Catalogue Number: 38302
• Device Lot Number: JUBQ0115
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1