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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

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ETHICON INC. GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Irritation (2076)
Event Date 01/01/2014
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 additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications what is physician¿s opinion as to the etiology of or contributing factors to this event patient symptoms- describe the manifestation of reaction (location, severity, appearance, systemic or local reaction) does the patient have known allergic history to medical device, food or medications? was there any allergy testing performed? if yes, results? what is the patient's current status?.
 
Event Description
It was reported that the patient underwent an unknown procedure in 2012 and the mesh was implanted.Two years after the procedure, systemic diffuse reaction, fatigue, itchiness and skin reaction occurred.It was reported by the patient that she experienced allergic reaction from the mesh.The patient has been to numerous doctors in the hospital without any diagnosis and still has problems.The patient was given medical treatment, antihistamine and other.Additional information has been requested.
 
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Brand Name
GYNECARE TVT
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits-godet 20
neuchatel
SZ  
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key6994588
MDR Text Key90849697
Report Number2210968-2017-70742
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K974098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 10/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/03/2017
Initial Date FDA Received11/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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