(b)(4).Additional information: the customer reports the following two batch numbers: jlp402 and jgh188.A review of the batch manufacturing records was conducted for the possible lots and the batch met all finished goods release criteria.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: initial procedure date ¿ (b)(6) 2016.Incision size? ¿ approx.26cm.Please provide details on how the product was applied? ¿ per ifu.Was the mesh placed over the entire length of the incision? - yes.Was the dermabond liquid adhesive placed to cover the entire length of the mesh? - yes.Did the prineo mesh extend beyond the patient incision? - yes.Was a dressing placed over the incision? if so, what type of cover dressing used? - no.What was done to address the patients pain? any medications prescribed? ¿ not reported.Was the product removed? was another method used to close the incision? ¿ yes, not reported.Lot number involved ¿ jlp402 & jgh188.What is the physicians opinion of the contributing factors to the event? ¿ not reported.What is the most current patient status? ¿ not reported.Is the product or representative sample (product from the same lot number) available for evaluation? - no.Patient demographics: initials / id; age or date of birth; bmi ¿ not reported.Patient pre-existing medical conditions ¿ not reported.Please clarify is the product code involved clr602us or clr222us? clr222us was the product code used.Were 2 prineo products used on the patient? yes, 2 were required on this patient to cover the incision.
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