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Catalog Number 810041BL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Burning Sensation (2146)
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Event Date 08/06/2021 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and mesh was implanted.The patient reported experiencing very intense permanent burns from morning to evening, pelvic pain, and pain on the right side of the belly and lower back on the right radiating into the buttock.The patient saw the surgeon again on (b)(6) 2021 who told the patient that the strip was not related to all these pains.The patient was prescribed lyrica 75 mg, drug that shooted the patient.The patient saw the doctor again another time, and asked for a cystoscopy.The doctor told the patient again that the strip was not the cause of the pain and could not do anything.The patient was given a prescription for 50 mg lyrica, and had to restart the pain center to have an appointment.No further information is available as the patient contact details were not disclosed.
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Manufacturer Narrative
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(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
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Search Alerts/Recalls
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