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Catalog Number UNKAA013 |
Device Problems
Defective Device (2588); Insufficient Information (3190)
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Patient Problems
Pain (1994); Injury (2348); Disability (2371)
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Event Type
Injury
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Manufacturer Narrative
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Based on the information provided, no conclusions can be made.A lot number has not been provided; therefore, we are unable to review the manufacturing records of the lot in question.The information is limited at this time and medical records have not been provided.Should additional information be provided a supplemental emdr will be submitted.Not returned.
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Event Description
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It is alleged by the patient's attorney that the patient underwent surgery for the implant of an unspecified bard/davol collamend mesh on (b)(6) 2007.As reported, the patient is making a claim for an adverse patient outcome against the collamend mesh.The attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.".
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Event Description
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It is alleged by the patient's attorney that the patient underwent surgery for the implant of an unspecified bard/davol collamend mesh on (b)(6) 2007.As reported, the patient is making a claim for an adverse patient outcome against the collamend mesh.The attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.".
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Manufacturer Narrative
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Based on the information provided, no conclusions can be made.A lot number has not been provided; therefore, we are unable to review the manufacturing records of the lot in question.The information is limited at this time and medical records have not been provided.Should additional information be provided a supplemental emdr will be submitted.This is an addendum to the initial emdr to make a correction to the manufacturing site.
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Search Alerts/Recalls
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