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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
Catalog Number MESHUNK
Device Problem Migration (4003)
Patient Problems Abscess (1690); Erosion (1750); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Blood Loss (2597); Not Applicable (3189)
Event Date 07/26/2019
Event Type  Injury  
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 following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. If in your possession, may we have copies of your operative reports 2005, 2007, 2008 and final removal in 2019? does ethicon have your permission to contact your surgeons, in the event ethicon would like to contact your surgeons for more clinical information to be used for a product quality complaint investigation? if so, please review and sign release of medical information form attached in order to contact your surgeons for additional information? note: events occurred after mesh #1 implanted in 2005 and mesh # 2 implanted in 2007 were captured in the related files and submitted via 2210968-2019-87949, 2210968-2019-87961 and 2210968-2019-87966 accordingly.
 
Event Description
It was reported that the patient underwent a gynecological procedure in (b)(6) 2008 and the unknown mesh was implanted to replace the previous implanted mesh due to recurrent bladder prolapse. The patient was released on (b)(6) 2008. Starting in 2017 to the mesh removal in 2019, the patient went through multiple doctors. It was reported that skin was growing into the mesh which disintegrated and embedded in her skin. The patient experienced a pain, uncontrollable discharge and an odor. The doctor opined that the odor was coming from the mesh, but it was not confirmed. The patient was having bleeding because the mesh tore into her vaginal walls. The patient was treated with estrogen cream internally applied to help the lining of the vaginal wall. It was also reported that the doctors were attempting to thicken the patient¿s skin to fix the issue. In 2019 the patient had excessive vaginal bleeding. Due to previously done hysterectomy on unknown date, the vaginal bleeding was not expected. On (b)(6) 2019, the patient underwent a mesh removal surgery which should be outpatient procedure but due to the length of the surgery the patient was kept and later released on (b)(6) 2019. It was found that the mesh was ripped in pieces and it was a little more sensitive to remove it. The patient developed excessive bleeding post-surgery, serious abdominal pain and was unable to walk. She was receiving a codeine, morphine and ibuprofen 800mg. At the beginning it was twice a day, and then it was as needed. The patient was readmitted to the hospital on (b)(6) 2019. Blood work showed that the patient needed a blood transfusion requiring two pints of blood. An ultrasound was performed, and it was then determined that the patient had the abscess, 8cm in diameter filled blood and puss. The doctor opined that it was from the development of the bacterial infection from the mesh. It was also reported that when it was measured it was believed to of been within the patient for a while, exact time frame unknown. The patient was given zosyn an antibiotic for the bacterial infection. On (b)(6) 2019 the drainage was started for abscess and bad odor continued. The patient was released from the hospital on (b)(6) 2019 with antibiotic amoxicillin clav. Three days later, a drain was removed, but the patient was still experiencing nausea, bad odor and pain, lost at least seven pounds and unable to walk. The patient is barely getting her strength back, gaining appetite, has a pain 4-5, more motivated, move around better and still has some nausea. Two weeks ago the patient couldn't keep food down and was having mobility issues again. The next day, she's feeling better but still having nausea issues. The patient has had vomiting, sometimes just nausea occasionally vomiting. On 09/05/2019, the patient has a follow up appointment to check the blood work and make sure that everything is removed, that there is no bacterial infection left. 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 NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876-0151
6107428552
MDR Report Key9101290
MDR Text Key162278467
Report Number2210968-2019-87970
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMESHUNK
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 Received12/17/2019
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/20/2019 Patient Sequence Number: 1
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