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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 Autoimmune Disorder (1732); Hearing Impairment (1881); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Memory Loss/Impairment (1958); Pain (1994); Sepsis (2067); Blurred Vision (2137); Spinal Cord Injury (2432); Ambulation Difficulties (2544); Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559)
Event Date 01/05/2017
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). (b)(4) device not returned.   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 a copy of your operative report(s)? 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 a patient underwent a prolapse procedure on an unknown date and the mesh was implanted. It was reported that the patient had so many problems over the years because of the device. It was reported that the patient couldn't stand for long periods of time, couldn't walk far, had heavy bleeding and back pain. It was reported that the device broke away from the patient¿s spine after nine years. It was reported that the device damaged the patient¿s spine, bowel, and bladder. It was also reported that the patient is now disabled suffers from chronic pain in the spine and vagina. It was also reported that the patient had most of the device removed along with a lot of tissue through surgery when the patient contracted sepsis underwent a blood transfusion. There are still fibers inside the patient that couldn't be removed, that caused autoimmune problems. It was also reported that the patient has vision, hearing, memory problems, skin lesions, bowel and bladder problems, fibromyalgia, chronic pain, chronic water, and vaginal infections. It was reported that the patient has become immune to antibiotics. It was also reported that the patient underwent a spine fusion, but it was too late before the damage from the device had been done so it was removed. It was also reported that the patient doesn¿t sleep and has a poor quality of life. It was reported that the patient suffers every day with all the problems. It was also reported that when the patient had the mesh fitted, the revision scar was repaired twice because it looked like i had been butchered. 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
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12126015
MDR Text Key260221457
Report Number2210968-2021-06029
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation
Type of Report Initial
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2021
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: 07/07/2021 Patient Sequence Number: 1
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