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U.S. Department of Health and Human Services

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

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ETHICON INC. GYNECARE TVT OBTURATOR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number 810081
Device Problem Material Erosion (1214)
Patient Problems Erosion (1750); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Pain (1994); Surgical procedure (2357); Blood Loss (2597); No Code Available (3191)
Event Type  Injury  
Event Description
It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2006 and a mesh was implanted.It was reported that the patient experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.
 
Manufacturer Narrative
(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
 
Manufacturer Narrative
(b)(4).It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2006 and a mesh was implanted, concurrently with a hysterectomy due to pop, and sui.No additional information was provided.
 
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Brand Name
GYNECARE TVT OBTURATOR SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits-godet 20 2000 neuchatel
neuchatel
SZ  
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key4666204
MDR Text Key5609359
Report Number2210968-2015-04094
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/15/2016
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
Device Catalogue Number810081
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/30/2015
Initial Date FDA Received04/07/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/16/2016
Was Device Evaluated by Manufacturer? No
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;
Patient Age44 YR
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