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U.S. Department of Health and Human Services

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

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ETHICON INC. GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problems Incontinence (1928); Unspecified Infection (1930); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Treatment with medication(s) (2571)
Event Type  Injury  
Event Description
It was reported by the patient that a gynecological procedure was performed in 2009 and mesh was implanted.Post-procedure, the patient has experienced severe continual pain in the lower back, stomach and down both legs.She has repeated urinary tract infections treated with antibiotics and reports increased incontinence.Her sleep has been affected due to pain and frequent urination.Additional information was not 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.
 
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Brand Name
GYNECARE PROLIFT 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 Key4570560
MDR Text Key16854857
Report Number2210968-2015-02496
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 02/11/2015
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/10/2015
Initial Date FDA Received03/04/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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