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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT OBTURATOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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ETHICON INC. GYNECARE TVT OBTURATOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number 810081
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Granuloma (1876); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Anxiety (2328); Ambulation Difficulties (2544)
Event Date 05/25/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Date sent to the fda: 12/13/2017.(b)(4).The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at the later date, a supplemental medwatch will be sent.
 
Event Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2017 and the mesh was implanted.Since the day after the procedure, the patient experienced anxiety, stress, constant pain in the sciatic area, down both left and right legs, in the groin area, vaginal area and bowel area.The patient also developed a rash and underwent a biopsy test which came back as granuloma annulare.Then after that diagnosis, the patient developed burn like rashes under both left and right armpits as well as inner elbow areas.It caused the patient pain and in (b)(6) 2017 the patient was told that it is an allergic reaction to the mesh and the mesh needs to be removed.The patient can no longer go walking or bike riding nor do any far distance travelling due to the pain in areas mentioned before.The patient is seeking for appointment for a full removal of mesh device.No further information is available.
 
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Brand Name
GYNECARE TVT OBTURATOR
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits-godet 20
neuchatel
SZ  
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7114093
MDR Text Key94737138
Report Number2210968-2017-71759
Device Sequence Number1
Product Code OTN
UDI-Device Identifier10705031000346
UDI-Public10705031000346
Combination Product (y/n)N
PMA/PMN Number
K033568
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 11/23/2017
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
Device Expiration Date10/31/2017
Device Catalogue Number810081
Device Lot Number3928519
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/23/2017
Initial Date FDA Received12/13/2017
Date Device Manufactured10/22/2016
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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