MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ROCHESTER MEC ULTRAFLEX I 30BX

Model Number	33303
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	04/25/2017
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 information provided by bard 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 bard.
Event or Problem Description
It was reported that the adhesive was too strong.The removal of the device was very painful, even with the assistance of water and other aids, and allegedly irritated the patient's skin.
Additional Manufacturer Narrative
The reported issue was unconfirmed.The device was returned and visually inspected.Visual inspection noted no obvious defects.Functional testing results were found within specification.The acceptable peel strength must be in a range from 0.60 to 2.60 lbf for a male external catheter and the sample results were: sample 1: 1.40 lbf, sample 2: 1.29 lbf, sample 3: 1.36 lbf.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states 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.Precautionlergic 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.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.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 was too strong.The removal of the device was very painful, even with the assistance of water and other aids, and allegedly irritated the patient's skin.

• Brand Name: ROCHESTER MEC ULTRAFLEX I 30BX
• Common Device Name: MEC
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 6593579
• Report Number: 1018233-2017-02724
• Device Sequence Number: 10963035
• Product Code: NNX
• UDI-Device Identifier: 00801741070778
• UDI-Public: (01)00801741070778(10)NGAS3780
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/13/2017

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: 04/30/2021
• Device Model Number: 33303
• Device Catalogue Number: 33303
• Device Lot Number: NGAS3780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1