MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 25MM 30BX; SPIRIT MALE EXTERNAL CATHETER - STYLE 1

Model Number	35301
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	Skin Irritation (2076); Discomfort (2330)
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 adhesive on the male external catheters was too strong and very difficult to remove.The patient indicated that his skin was irritated and dry.The patient's wife advised via phone on (b)(6) 2019, that the removal techniques she was offered worked well.However, her husband's skin was still dry but was getting better.
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: ¿description/indication the self-adhering male external catheter is designed for the management of male urinary incontinence.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 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) unroll self-adhering catheter over penis.4) 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.5) 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".
Event or Problem Description
It was reported that the adhesive on the male external catheters was too strong and very difficult to remove.The patient indicated that his skin was irritated and dry.The patient's wife advised via phone on 2019, that the removal techniques she was offered worked well.However, her husband's skin was still dry but was getting better.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 25MM 30BX
• Common Device Name: SPIRIT MALE EXTERNAL CATHETER - STYLE 1
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8383194
• Report Number: 1018233-2019-01108
• Device Sequence Number: 1783694
• Product Code: NNX
• UDI-Device Identifier: 00801741070921
• UDI-Public: (01)00801741070921
• 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): 03/28/2019

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: 35301
• Device Catalogue Number: 35301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1