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

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.

• 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 Key: 6994588
• MDR Text Key: 90849697
• Report Number: 2210968-2017-70742
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• 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

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention