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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 29MM 30BX

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C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 29MM 30BX Back to Search Results
Model Number 35302
Device Problems Device Contamination with Body Fluid (2317); Patient-Device Incompatibility (2682)
Patient Problems Unspecified Infection (1930); Blood Loss (2597); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the patient experienced a bladder infection that caused him to see blood in the male external catheter.
 
Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿biocompatibility¿.A potential root cause for this failure could be ¿materials not biocompatible".The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and 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.5) 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." h11:section a through f - the information provided by bd 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 bd.The device was not returned.
 
Event Description
It was reported that the patient experienced a bladder infection that caused him to see blood in the male external catheter.
 
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Brand Name
ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 29MM 30BX
Type of Device
MEC
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9633423
MDR Text Key176463250
Report Number1018233-2020-00530
Device Sequence Number1
Product Code NNX
UDI-Device Identifier00801741070938
UDI-Public(01)00801741070938
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 01/30/2020
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? No
Device Operator Lay User/Patient
Device Model Number35302
Device Catalogue Number35302
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/06/2020
Initial Date FDA Received01/27/2020
Supplement Dates Manufacturer Received01/28/2020
Supplement Dates FDA Received01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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