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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
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ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Unspecified Infection (1930); Pain (1994); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported that the patient underwent a gynecological procedure on an unknown date and mesh was implanted.The patient reported that the mesh cut through the vaginal wall six times causing pain, infection and calcification at the vaginal entrance.The mesh was removed on an unknown date.No additional information was provided.
 
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Brand Name
TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7383346
MDR Text Key103914239
Report Number2210968-2018-71768
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
PMA/PMN Number
K033568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 03/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2018
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 Received03/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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