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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 Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Burning Sensation (2146); Blood Loss (2597); No Code Available (3191)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
Date sent to fda: 12/21/2018. Additional narrative: it was reported that the patient has complaints of problems with marital intercourse. No additional information was provided.
 
Manufacturer Narrative
(b)(4). 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. Attempts are being made to obtain the following information. To date no response has been provided. If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation?.
 
Event Description
It was reported that the patient underwent an unknown gynecological procedure on an unknown date and mesh was implanted. Seven weeks after the procedure, the patient reported burning, bleeding and severe pain. The patient has been taking medication and lying down during the day with ice packs to relieve the pain. No additional information was provided.
 
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Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key6974325
MDR Text Key251313244
Report Number2210968-2017-70637
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2017
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/24/2017 Patient Sequence Number: 1
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