There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient.
The sample was not returned for evaluation.
Based on the limited information provided at this time, no conclusions can be made.
Inflammation is identified in the adverse reaction section of the instructions-for-use as a possible complication.
No lot number was provided therefore a review of the manufacturing records is not possible at this time.
Based on the date of implant the subject product is part of the composix kugel recall initiated on (b)(4) 2005.
Should additional information be provided a supplemental 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.
Not returned.
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The following was alleged by the patient's attorney:on (b)(6) 2006: the patient underwent a hernia surgery for a ventral hernia and umbilical hernia.
As reported, the patient's hernia was repaired with a bard/davol 11.
4cm x 11.
4cm oval kugel patch, product code 0010204.
It is alleged that sometime after placement the device malfunctioned by, inter alia, contracting, suffering degradation, and causing an intense foreign body and inflammatory response.
It is alleged that as a result of these failures, the patient has suffered severe injuries, required substantial medical care, has suffered and will continue to suffer physical pain.
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