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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - SECUR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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ETHICON INC. TENSION FREE VAGINAL TAPE - SECUR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number TVTS1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); 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) 2007 and mesh was implanted due to sui.It was reported that the patient underwent mesh revision on (b)(6) 2011 due to recurrent incontinence.No additional information was provided.
 
Manufacturer Narrative
Date sent to the fda: 11/18/2020.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
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Brand Name
TENSION FREE VAGINAL TAPE - SECUR
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10821833
MDR Text Key216379811
Report Number2210968-2020-08839
Device Sequence Number1
Product Code PAH
Combination Product (y/n)N
PMA/PMN Number
K052401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2008
Device Catalogue NumberTVTS1
Device Lot Number2964321
Was Device Available for Evaluation? No
Date Manufacturer Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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