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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN

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ETHICON INC. GYNECARE MESH UNKNOWN Back to Search Results
Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)
Patient Problems Erosion (1750); Nerve Damage (1979); Pain (1994); Perforation (2001); Ambulation Difficulties (2544); No Code Available (3191)
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. Http://www. Bbc. Com/news/health-39567240-article link.
 
Event Description
It was reported in a journal article that the patient underwent an unknown procedure between (b)(6) 2007 and (b)(6) 2015 and the unknown vaginal mesh was implanted. Following the procedure, the patient experienced possibly permanent pain, chronic pain or pain three years after the procedure, discomfort, dyspareunia, unable to walk, and/or severe perforation cause injury during sex. After the examination, it was possibly indicated that the mesh could be seen coming through vagina. The patient was possibly admitted multiple times to the hospital in attempt to end the pain. The patient, probably, is on high-dose medication, including opiates. It was also possible that the patient has the mesh located near a nerve resulting in nerve damage and permanent pain, and could not be fully removed. No further information is available.
 
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Brand NameGYNECARE MESH UNKNOWN
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
UNKNOWN
unknown
x
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6575715
MDR Text Key75459313
Report Number2210968-2017-32156
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2017
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 Received04/19/2017
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/18/2017 Patient Sequence Number: 1
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