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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 Problem Migration (4003)
Patient Problems Erosion (1750); Pain (1994); 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) 2009 and mesh was implanted, due to sui.It was reported that she underwent mesh excision on (b)(6) 2012 due to mesh erosion.No additional information was provided.
 
Manufacturer Narrative
Additional b5 narrative: it was reported that the patient experienced severe pelvic pain.Date sent to the fda: 1/26/2021.Corrected b5 narrative: it was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2009, and mesh was implanted.
 
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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 Key9346604
MDR Text Key167126684
Report Number2210968-2019-90115
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 11/19/2019
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 11/19/2019
Initial Date FDA Received11/20/2019
Supplement Dates Manufacturer Received01/20/2021
Supplement Dates FDA Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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