As reported, the implanted ventralight st mesh tore from the surgical site.
It is unclear at this time what symptoms the patient experience and what treatment was provided.
The information provided is limited to the maude event report.
Contact information was not provided, as such we are unable to request additional information.
Based on the information available at this time, no conclusions can be made.
To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february, 2018.
A review of the manufacturing records was performed and found that the lot was manufactured to specification.
Should additional information be provided, a supplemental mdr will be submitted.
Not returned.
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