MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 41MM 100BX

Model Number	35105
Health Effect - Clinical Code	No Information (3190)
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 adhesive of the catheter was too strong.
Additional Manufacturer Narrative
Received 5 hydrocolloid adhesive sheath lot samples.The reported event was unconfirmed, since the samples met specification.The samples were visually inspected for holes or damage on the package, legibility of printed numbers and letters, expiration date, correct impression, print color, missing parts of printing, position of printing, damaged component, foreign matter.Per functional testing, the samples were evaluated according to the alleged failure mode: "strong adhesive" and were found within specification, acceptable peel strength must be in a range from 0.60 to 2.10 lbf.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: "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 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" (b)(4).
Event or Problem Description
It was reported that the adhesive of the catheter was too strong.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 41MM 100BX
• Common Device Name: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7000098
• Report Number: 1018233-2017-05685
• Device Sequence Number: 13677958
• Product Code: NNX
• UDI-Device Identifier: 00801741070914
• UDI-Public: (01)00801741070914
• 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: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: 06/28/2021
• Device Model Number: 35105
• Device Catalogue Number: 35105
• Device Lot Number: JUAT0870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1