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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC
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ETHICON INC. ULTRAPRO MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2014 and mesh were  implanted.It was reported that she experienced undisclosed injuries.It was reported that the patient underwent a revision on an unknown date.No additional information was provided.
 
Manufacturer Narrative
Date sent to fda: 1/15/2019.Additional narrative: it was reported that following the procedure the patient had micturition frequency, urinary incontinence, urgency, retention and infection.No additional information was provided.
 
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Brand Name
ULTRAPRO MESH UNKNOWN PRODUCT
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8014348
MDR Text Key125304763
Report Number2210968-2018-76551
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K033337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received01/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ULTRAPRO AND PROLENE MESH; ULTRAPRO AND PROLENE MESH
Patient Outcome(s) Required Intervention;
Patient Age54 YR
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