MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 36MM 30BX; MALE EXTERNAL CATHETER

Model Number	35304
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
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 patient stated the external 36 mm spirit catheters allegedly caused a urinary tract infections.However, there was no treatment by a medical doctor, and no medical intervention was reported.
Event or Problem Description
It was reported that the patient stated the external 36mm spirit catheters allegedly caused a urinary tract infections.However, there was no treatment by a medical doctor, and no medical intervention was reported.
Additional Manufacturer Narrative
The reported event could not be confirmed.It was unknown whether the device had met specifications due to no sample was returned for evaluation.The product was used for treatment purposes.A potential failure mode could be ¿biocompatibility¿ with a potential root cause of ¿materials not biocompatible¿.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: "contraindication do not use on irritated or compromised skin.Precaution do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply wash penis with mild soap and warm water.Dry thoroughly.Trim pubic hair if necessary.Unroll self-adhering catheter over penis.Gently squeeze the catheter to properly seal adhesive to the skin.Important: wear: time may be significantly reduced if adhesive is not properly sealed to the skin.Connect to drainage device.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.".

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 36MM 30BX
• Common Device Name: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9280088
• Report Number: 1018233-2019-07054
• Device Sequence Number: 2183532
• Product Code: NNX
• UDI-Device Identifier: 00801741070952
• UDI-Public: (01)00801741070952
• 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): 11/15/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 35304
• Device Catalogue Number: 35304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 11/15/2019
• 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: Other