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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 41MM 100BX Back to Search Results
Model Number 35105
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the adhesive of the catheter was too strong.
 
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 Description
It was reported that the adhesive of the catheter was too strong.
 
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Brand Name
ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 41MM 100BX
Type of Device
MEC
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7000098
MDR Text Key91924636
Report Number1018233-2017-05685
Device Sequence Number1
Product Code NNX
UDI-Device Identifier00801741070914
UDI-Public(01)00801741070914
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 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
Device Operator Lay User/Patient
Device Expiration Date06/28/2021
Device Model Number35105
Device Catalogue Number35105
Device Lot NumberJUAT0870
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/18/2017
Initial Date FDA Received11/03/2017
Supplement Dates Manufacturer Received01/29/2018
Supplement Dates FDA Received02/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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