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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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ETHICON INC. TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)
Patient Problems Adhesion(s) (1695); Erosion (1750); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
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.It was reported that the patient underwent revision surgery on (b)(6) 2019.No additional information was provided.It was reported plaintiff experienced pain.No additional information was added.
 
Manufacturer Narrative
Date sent to the fda: 02/24/2021.Additional information: a2, d6b.Additional b5 narrative: it was reported that the patient underwent vaginal mesh removal on (b)(6) 2019.It was reported that the patient experienced erosion, adhesion.
 
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Brand Name
TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10948562
MDR Text Key219847364
Report Number2210968-2020-09596
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 other
Type of Report Initial,Followup
Report Date 12/02/2020
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 Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/02/2020
Initial Date FDA Received12/04/2020
Supplement Dates Manufacturer Received02/22/2021
Supplement Dates FDA Received02/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age33 YR
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