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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 Incontinence (1928); Pain (1994)
Event Type  Injury  
Event Description
It is reported in the intimation of claim that the complainant underwent a pelvic floor repair procedure on (b)(6) 2009 and a mesh was implanted.The patient underwent further procedures on (b)(6) 2009 and on (b)(6) 2010 and mesh devices were implanted.Following the surgery she has experienced intense pain in her vagina and back passage and continued to suffer problems with incontinence.
 
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).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 0151
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits-godet 20 2000 neuchatel
neuchatel
SZ  
Manufacturer Contact
mary szaro
route 22 west po box 151
somerville, NJ 08876
9082183464
MDR Report Key4785785
MDR Text Key5799250
Report Number2210968-2015-06101
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K071512
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial
Report Date 05/15/2015
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 Date09/30/2011
Device Catalogue NumberPFRA01
Device Lot Number3222412
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/15/2015
Initial Date FDA Received05/20/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/14/2008
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 Age50 YR
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