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Catalog Number 830041BL |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Erosion (1750); Pain (1994); Not Applicable (3189)
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Event Date 10/08/2011 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure? name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? other relevant patient history/concomitant medications? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was current urethral pain occurred? character of pain? what medical intervention was given for the pain management? results? was the cystoscopy performed already? results? is the device planned to be removed or removed already? if so, please provide a date and details of the re-operation.What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? note: reported adverse event of mesh exposure on (b)(6) 2011 was reported via 2210968-2018-77760.
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Event Description
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It was reported that the patient underwent gynecological procedure in (b)(6) 2011 and mesh was implanted.On (b)(6) 2011, the patient experienced mesh exposure in vagina and underwent resuturing of vaginal mesh.On (b)(6) 2011, the patient underwent excision of 10mm x 3mm exposed mesh in vagina.Additional information has been requested.
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Search Alerts/Recalls
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