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Catalog Number UNKAA107 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Nerve Damage (1979); Pain (1994)
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Event Date 06/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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Based on the information provided, no conclusion can be made.We are unable to contact the reporter for additional information.No lot number has been provided; therefore, a review of the manufacturing records is not possible.As reported, the patient experienced pain, and migration post implant of the onflex mesh.The adverse reactions section of the instructions for use, supplied with this device lists, pain and migration as possible complications.Note, the date of event and date of implant are considered to be a best estimate as (b)(6) 2019 based on the available information.Should additional information be provided, a supplemental mdr will be submitted.Not returned.
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Event Description
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As alleged, the patient was implanted with a bard/davol onflex mesh.It was reported that the surgery took place "two years ago".It is alleged that the patient has had pain since surgery and allegedly an mri shows the mesh has migrated and is damaging other areas of the body.As reported, "the mesh will probably be removed as it seems to be hurting his nerves and one testicle." as reported, the patient's doctor has proposed to re-operate.It is reported that the patient wants to continue in the pain clinic at this time and does not want to undergo re-operation.
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Event Description
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As alleged, the patient was implanted with a bard/davol onflex mesh.It was reported that the surgery took place "two years ago".It is alleged that the patient has had pain since surgery and allegedly an mri shows the mesh has migrated and is damaging other areas of the body.As reported, "the mesh will probably be removed as it seems to be hurting his nerves and one testicle." as reported, the patient's doctor has proposed to re-operate.It is reported that the patient wants to continue in the pain clinic at this time and does not want to undergo re-operation.
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Manufacturer Narrative
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Based on the information provided, no conclusion can be made.We are unable to contact the reporter for additional information.No lot number has been provided; therefore, a review of the manufacturing records is not possible.As reported, the patient experienced pain, and migration post implant of the onflex mesh.The adverse reactions section of the instructions for use, supplied with this device lists, pain and migration as possible complications.Note, the date of event and date of implant are considered to be a best estimate as (b)(6) 2019 based on the available information.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to remove the udi number, which was entered inadvertently in the initial mdr.Should additional information be provided, a supplemental mdr will be submitted.
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Search Alerts/Recalls
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