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Catalog Number 0112650 |
Device Problems
Defective Device (2588); Insufficient Information (3190)
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Patient Problem
Hernia (2240)
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Event Date 09/18/2001 |
Event Type
Injury
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Manufacturer Narrative
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Currently, it is unknown whether the device may have caused or contributed to the reported event.Limited information was provided and no conclusions can be made.A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned to manufacturer.
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Event Description
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The following is based on a review of medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 1999- the patient was diagnosed with menorrhagia and incisional hernia.The patient underwent diagnostic hysteroscopy, fractional dilation and curettage, endometrial ablation and open repair of incisional hernia with davol flat mesh.On (b)(6) 2001 - per the patient's legal claim the patient underwent umbilical hernia repair.No medical records provided for this procedure.On (b)(6) 2004 - per the patient's legal claim the patient underwent repair of incarcerated recurrent incision hernia.No medical records provided for this procedure.
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Manufacturer Narrative
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The following supplemental emdr was sent to correct the date of event.The correct date of event should be (b)(6) 2001.With the current information no conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Search Alerts/Recalls
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