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

Model Number	35304
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Skin Irritation (2076)
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.
Event or Problem Description
It was reported that the patient had difficulty removing the adhesive from the spirit style catheter.As a result the patient experienced skin irritation.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be "device is difficult to remove" due to a potential root cause of "adhesive is too strong".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." correction: d10.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the patient had difficulty removing the adhesive from the spirit style catheter.As a result the patient experienced skin irritation.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 36MM
• 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: 8816145
• Report Number: 1018233-2019-04150
• Device Sequence Number: 2562598
• 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): 08/12/2019

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: 35304
• Device Catalogue Number: 35304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1