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Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Irritation (2076)
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Event Date 01/01/2014 |
Event Type
Injury
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Manufacturer Narrative
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(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?.
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Event Description
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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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Search Alerts/Recalls
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