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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON SARL GYNECARE TVT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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ETHICON SARL GYNECARE TVT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number 830041BL
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); No Code Available (3191)
Event Date 12/05/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).In addition, a 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 a later date a supplemental medwatch will be sent.
 
Event Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2016 and the mesh was implanted.At (b)(6) follow up, the mesh exposure was noted in a midline over incision.The patient listed for revision under general anesthesia.No further information is available.
 
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Brand Name
GYNECARE TVT RETROPUBIC SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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 Key6208291
MDR Text Key63368171
Report Number2210968-2016-36949
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K012628
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 12/07/2016
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 Expiration Date02/28/2019
Device Catalogue Number830041BL
Device Lot Number3901351
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/07/2016
Initial Date FDA Received12/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2016
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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