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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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ETHICON INC. GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number PFRA01
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problems Bleeding (1738); Incontinence (1928); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)
Event Type  Injury  
Event Description
It was reported, by the patient, that they underwent a gynecological procedure in 2007 and mesh was implanted.The patient states that the mesh did not repair the pelvic floor, caused major incontinence issues, vaginal bleeding, and further prolapse.The patient underwent an unspecified number of additional procedures to repair the pelvic floor, repair the bladder and remove exposed mesh which she reports were unsuccessful.No additional information was provided.
 
Manufacturer Narrative
(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
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Brand Name
GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 015
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 Key4603848
MDR Text Key5701615
Report Number2210968-2015-02973
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
PMA/PMN Number
K013718
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/23/2015
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 Date03/31/2010
Device Catalogue NumberPFRA01
Device Lot Number3025722
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/23/2015
Initial Date FDA Received03/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2007
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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