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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON / JOHNSON & JOHNSON STAP LIGACLIP EL5ML
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ETHICON / JOHNSON & JOHNSON STAP LIGACLIP EL5ML Back to Search Results
Model Number EH8GKPAO
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Diarrhea (1811); Fever (1858); Nausea (1970); Pain (1994); Vomiting (2144); Urinary Frequency (2275); Disability (2371); Sweating (2444); Constipation (3274)
Event Date 11/19/2012
Event Type  Injury  
Event Description
Has hernia repair.Had to be admitted to hospital a couple hours after surgery nausea vomiting vile, went back to work couldn't handle the pain and i have been disabled since (b)(6) 2013, and i still have problems every day with constipation, pain, diarrhea, fever, sweats, leg and thigh feels like something tearing, kidney bladder hurts, urinate frequently and this product should be recalled because i believe it has been my problem.It has taken my life and my quality of life from me.Please i'm a human in need of help.I haven't been able to go to the doctor and i'm very scared to go under again because i feel like i almost died the first time.Ethicon physio hernia mesh inside me, hurting me, my body and my life.
 
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Brand Name
STAP LIGACLIP EL5ML
Type of Device
STAP LIGACLIP EL5ML
Manufacturer (Section D)
ETHICON / JOHNSON & JOHNSON
MDR Report Key6812723
MDR Text Key83530145
Report NumberMW5071749
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/21/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date06/30/2014
Device Model NumberEH8GKPAO
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/23/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Disability;
Patient Weight68
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