(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Initial procedure date.What was the angle of the knee during application? please describe how was the adhesive applied on the tape.What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? lot number involved.What is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender.Patient pre-existing medical conditions (ie.Allergies, history of reactions).Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.
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Product complaint # = > (b)(4).Additional information was requested and the following was obtained: 1.Initial procedure date - (b)(6) 2018.2.What was the angle of the knee during application? - 90 degrees.3.Please describe how was the adhesive applied on the tape.- mesh over wound in blanket fashion, followed by 2 octyl cyanocrylate.4.What prep was used prior to, during or after prineo use? - iodine.5.Was a dressing placed over the incision? if so, what¿s type of cover dressing used? - yes.Meplex border post-op.6.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? - no.7.Is the patient hypersensitive to pressure sensitive adhesives? - no.8.Were any patch or sensitivity tests performed? - no.9.Lot number involved - not able to find.10.What is the physicians opinion of the contributing factors to the reaction? - properties of prineo.11.What is the most current patient status? - recovered.12.Is the product or representative sample (product from the same lot number) available for evaluation? - n/a.13.Patient demographics: initials / id; age or date of birth; bmi ; gender - n/a.14.Patient pre-existing medical conditions (ie.Allergies, history of reactions) - none.15.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? - no.
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