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Catalog Number 810081L |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
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Patient Problems
Pain (1994); Burning Sensation (2146); Prolapse (2475)
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Event Date 04/01/2023 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a sling procedure on (b)(6) 2015 and mesh was implanted.The patient reported having a lump that was bothering in the vagina.The gynecologist told the patient that the bladder had descended and saw the mesh was broken.The patient reported experiencing pain in the groin, stomach, hip, limping when walking, pain at the entrance to the vagina, very painful on the stomach when touched like burning and back pain like sciatica.No further information is available as the reporter contact information was 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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