MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC WIDEBAND M 30BX

Model Number 36302

Device Problem Physical Property Issue (3008)

Patient Problem Pain (1994)

Event Date 05/05/2017

Event Type  malfunction  

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 Description

It was reported that the condoms had too much adhesive, and caused slight pain during removal.

Manufacturer Narrative

Received 3 unopened wideband mecs.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.The samples were evaluated according to the alleged failure mode: "too much adhesive".The evaluation could not confirm the reported event since the samples were within specification, the acceptable peel strength must be in a range from 0.80 to 2.80lbf for a wideband mec and sample results were: sample 1: 1.47 lbf, sample 2: 1.78 lbf, sample 3: 2.06 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: "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 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 Description

It was reported that the condoms had too much adhesive, and caused slight pain during removal.

• Brand Name: ROCHESTER MEC WIDEBAND M 30BX
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; parque industrial aeropuerto; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; parque industrial aeropuerto; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6595451
• MDR Text Key: 76237654
• Report Number: 1018233-2017-02750
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071041
• UDI-Public: (01)00801741071041
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2021
• Device Model Number: 36302
• Device Catalogue Number: 36302
• Device Lot Number: NGAR4507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1