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

Model Number 36304

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

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 sheaths were too sticky and difficult to remove.The patient reported on one occasion to had removed skin off their penis, resulting in an open wound approximately 15 mm x 8 mm, which resolved after 8 days.However, the patient did not seek medical intervention for the wound, but kept it clean.On another occasion, the patient had to cut the sheath off and a portion remained on the penis, as it was unable to be removed until a few days later.

Manufacturer Narrative

The reported event was unconfirmed.Received 5 mec lot samples for evaluation.No damages were noted during visual evaluation.Per the functional evaluation, all 5 samples were found within specification.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 sheaths were too sticky and difficult to remove.The patient reported on one occasion to had removed skin off their penis, resulting in an open wound approximately 15 mm x 8 mm, which resolved after 8 days.However, the patient did not seek medical intervention for the wound, but kept it clean.On another occasion, the patient had to cut the sheath off and a portion remained on the penis, as it was unable to be removed until a few days later.

• Brand Name: ROCHESTER MEC WIDEBAND L 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: 6758653
• MDR Text Key: 81561407
• Report Number: 1018233-2017-04085
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071089
• UDI-Public: (01)00801741071089
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Model Number: 36304
• Device Catalogue Number: 36304
• Device Lot Number: NGAT4366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2016
• 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
• Patient Outcome(s): Other