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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON SARL GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

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ETHICON SARL GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Burning Sensation (2146); No Code Available (3191)
Event Date 12/10/2010
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 an unknown surgical procedure on unknown date and the mesh was implanted.Following the procedure, the patient experienced a vaginal pain, rectal pain, vulvodynia, constant burning sensation in groin, inability to sit or stand, inability to work, inability to be intimate with spouse, bed-ridden and loss of livelihood.The mesh is still implanted.No further information is available.
 
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Brand Name
GYNECARE TVT
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
Manufacturer (Section D)
ETHICON SARL
puits-godet 20
neuchatel 2000
SZ  2000
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits-godet 20
neuchatel 2000
SZ   2000
Manufacturer Contact
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6211223
MDR Text Key63453032
Report Number2210968-2016-36950
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K974098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 12/08/2016
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
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/08/2016
Initial Date FDA Received12/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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