MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC WIDEBAND M; MALE EXTERNAL CATHETER

Model Number	36302
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Irritation (2076)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿tip wall thickness too thin¿.A potential root cause for this failure could be ¿improper manufacturing technique/s¿.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: wash penis with mild soap and warm water.Dry thoroughly.Trim pubic hair if necessary.Open package at perforation.To remove plastic insert, squeeze catheter at the top of the white cone and pull to release.Unroll self-adhering catheter over penis.Gently squeeze the catheter to properly seal adhesive to the skin.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.If necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.".
Event or Problem Description
It was reported that urine would not drain out of the male external catheter which allegedly made the patient's skin sore and caused an infection.Per additional information received from the customer contact via phone on (b)(6) 2019, the infection was treated with prescribed antibiotics from the patient's doctor.

• Brand Name: ROCHESTER MEC WIDEBAND M
• Common Device Name: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8892373
• Report Number: 1018233-2019-04697
• Device Sequence Number: 286534
• Product Code: NNX
• UDI-Device Identifier: 00801741071041
• UDI-Public: (01)00801741071041
• 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): 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 36302
• Device Catalogue Number: 36302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention