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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 Migration or Expulsion of Device (1395)
Patient Problems Adhesion(s) (1695); Erosion (1750); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
This medwatch report is being voided as it is a duplicate of medwatch report #: 2210968-2015-07233. Please see report # 2210968-2015-07233 for all information regarding this event.
 
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. 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? if so, please provide your surgeon¿s name, contact information. And sign release of medical information form attached.
 
Event Description
It was reported that the patient underwent an unknown surgical procedure on unknown date and the mesh was implanted. It was also reported that the device has eroded and adhered to the bladder leading to three surgeries in all. Because the patient experienced so much pain, the mesh was removed. As the patient stated, she has had five years of ill health, infections, destroyed bladder and she cannot even drink a coffee. The patient has to eat plain foods and nearly everything irritates the bladder causing endless pain and burning. The patient was taken nitrofurantoin for three years and amitriptyline for nerve damage. Additional information has been requested.
 
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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 Key7110589
MDR Text Key106200748
Report Number2210968-2017-71743
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
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 Received11/21/2017
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: 12/12/2017 Patient Sequence Number: 1
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