MAUDE Adverse Event Report: ROCHESTER MEDICAL CORP 2130787 ROCHESTER MEC ULTRAFLEX I 30BX

Catalog Number 33303

Device Problem Sticking (1597)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/19/2016

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 catheter had to much glue.The catheters stuck to his fingers and he could not use them.When used, he needed 20 minutes to remove the catheter.Patient reported that it was very painful and he had small wounds.

Manufacturer Narrative

Received 2 unopened ultraflex male external catheters in the original unit packaging.Per the functional evaluation, two samples were tested for adhesive peel strength.Both samples were found to be within specifications for adhesive peel strength.The specification is 0.600 to 2.100 pounds; the catheters measured 0.811 pounds and 0.920 pounds.The complaint could not be confirmed as the product met specifications.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.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.Non-sterile.Single use, use by date.Not made with natural rubber latex." (b)(4).

• Brand Name: ROCHESTER MEC ULTRAFLEX I 30BX
• Type of Device: MEC
• Manufacturer (Section D): ROCHESTER MEDICAL CORP 2130787; one rochester medical dr.; stewartville MN 55976
• Manufacturer (Section G): ROCHESTER MEDICAL CORP 2130787; one rochester medical dr.; stewartville MN 55976
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5734508
• MDR Text Key: 47702755
• Report Number: 1018233-2016-00770
• Device Sequence Number: 1
• Product Code: NNX
• 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: 06/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 33303
• Device Lot Number: NGZE0219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• 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