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Catalog Number 0010302 |
Device Problems
Defective Device (2588); Folded (2630)
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Patient Problems
Adhesion(s) (1695); Hernia (2240); Disability (2371)
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Event Date 04/15/2014 |
Event Type
Injury
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Manufacturer Narrative
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Currently, it is unknown to what extent the device may have caused or contributed to the reported event.
To date no medical records have been provided.
It is alleged the patient experienced pain, recurrence and adhesions.
Adhesions and recurrence are both listed as know possible adverse reactions in the instructions-for-use.
Currently with the information provided, it is unclear if the ventralex mesh was removed during the (b)(6) 2014 procedure as it was reported that the patient underwent additional surgery "to repair the hernia defect and remove it.
" it is unclear at this time what the "it" is referring to whether it was the previously implant ventralex mesh or the actual hernia itself.
A manufacturing review was performed which found no anomalies during the manufacturing process of the device.
With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications.
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 was reported to davol by the patient's attorney: (b)(6) 2005 - the patient underwent surgery for repair of an incisional hernia.
A ventralex hernia patch was implanted to repair the hernia defect.
On (b)(6) 2014 -the patient underwent an additional surgery to repair the hernia defect and remove it.
As a result of the ventralex failure, the mesh folded while inside her body causing pain, hernia recurrence, adhesions and scarring.
Patient was severely and permanently injured.
The attorney alleges the patient experienced pain, hernia recurrence, adhesions, scarring, disability and additional surgical procedure.
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Search Alerts/Recalls
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