(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.Additional information was requested and the following was obtained: how was the device applied to the incision? with knee flexed at 50 degrees.Please describe how the adhesive was applied on the tape? "painted on with the derma bond applicator supplied in the prineo kit.What prep was used prior to product application? chloraprep and the isopropyl alcohol.What was the location and incision size of the application? incision was ~20 cm vertical midline over anterior knee.Was a dressing placed over the incision? if so, what type of cover dressing used? after prineo a tell was placed after the derma bond dried then an ace wrap was applied.Please explain how the skin layers were closed to reduce skin tension? these were not tension blisters, they were small red papules that itched then formed small blisters but the skin was closed with inverted 2-0 vicryl <6 mm apart followed by the prineo.What date did the reaction occur on? on (b)(6) 2017 it was reported but began 1-2 days prior to reporting.What does the reaction look like and how large of an area does the reaction cover? it covered sporadically and involved 30% of the bodies surface and it is resolved now with only minor cosmetic deformities of the incision line now.Do you have any pictures of the reaction? yes.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Yes, product removed, medrol dose pak and keflex prescribed.Can you identify the product code and lot number of the product that was used? product code listed, lot number not recorded.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no - patient had a total knee replacement on the other knee 3 months prior with same prep, procedure, application of prineo - without any reaction.Was the patient exposed to similar products, such as artificial nails? no.What is the most current patient status? minor cosmetic deformities of the incision line.Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) (b)(6), allergies: tramadol.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? yes - patient had a total knee replacement on the other knee 3 months prior with same prep, procedure, application of prineo - without any reaction.
|
It was reported that a patient underwent a left knee replacement on (b)(6) 2017 and topical skin adhesive was used.On (b)(6) 2017 the patient returned to the doctor, complaining of blistering, oozing, and itching all over the body.The reaction covered sporadically and involved 30% of the bodies surface.The doctor removed the topical skin adhesive and prescribed medrol dose pak, keflex and benadryl.The reaction is now resolved with only minor cosmetic deformities of the incision line.The patient is currently doing fine.The patient had a previous total knee replacement on the other knee 3 months prior with same prep, procedure, and application of topical skin adhesive, without any reaction.Additional information was requested.
|
(b)(4).The patient's pre-patellar bursa was aspirated on (b)(4) 2017.Purulent fluid, positive cultures, patient taken to or on (b)(4) 2017 for open incision and drainage.The patient was started on iv vancomycin.The patient was then brought back to the or on (b)(4) 2017 for a second open incision and drainage and poly exchange.The patient is being seen by infectious disease and on iv antibiotics in the hospital waiting on picc line and discharge.
|