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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL

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ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Date 04/12/2011
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts are being made to obtain the following information.  to date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. What is the product code and lot # of the device used in this procedure? what is the physician's opinion as to the etiology of or contributing factors to this event?.
 
Event Description
It was reported that a patient underwent a sacrocolpopexy on (b)(6) 2010 and the mesh was implanted. It was reported that the patient experienced candidal vulvovaginitis that was classified with mild severity. It was reported that the patient was given drug therapy and the event ended on (b)(6) 2011. It was reported that the patient recovered, and the event resolved without sequelae. It was also reported that the event had an unlikely relationship to the study device and an unlikely relationship to the primary study procedure. Additional information was requested.
 
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Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key14131585
MDR Text Key293164262
Report Number2210968-2022-02701
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013718
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received04/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2009
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/16/2022 Patient Sequence Number: 1
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