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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 Abscess (1690); Erosion (1750); Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544); Not Applicable (3189)
Event Date 11/01/2011
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on social media by the patient that they underwent pop procedure in (b)(6) 2011 and mesh was used. In (b)(6) 2011, the patient reported they experienced the worst pelvic infection their doctor had seen. In 2012, the patient spent 74 days in hospital with pain from abscesses in the pelvis. The patient reported that the hospital went in to drain and put a hole in the bladder. The patient reported the infection from the mesh was so bad it ate though the bladder, colon, and fallopian tube. The patient reported they could not walk, stand, or sit, void or have a bowel movement. The patient reported they would eat then throw up, and patient ended up with streptococcus. The patient reported they could not work and is now disabled and in 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 NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
road 183, km. 8.3
san lorenzo
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7769738
MDR Text Key116650769
Report Number2210968-2018-75047
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 consumer,other
Reporter Occupation
Type of Report Initial
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
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 Received07/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/09/2018 Patient Sequence Number: 1
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