(b)(4).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: we thought it was the steri strips she was reacting too but we weren't able to tell which caused the reaction.What is the procedure name? pao, screw removal.What is the procedure date? unknown.How was the device was used (what layer of tissue and how many layers applied)? 1 layer used topically on skin.What was the location and incision size of prineo application? 10-12 cm on the hip.What prep was used prior to prineo application? chloraprep in the beginning of the case.No prep prior to use of prineo.Was the prep allowed to dry prior to prineo mesh application? n/a.Please describe how the adhesive was applied on the tape? tape was applied over the incision flush and patted down to assure adherence.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 with somewhat larger coverage beyond the perimeter.Did the prineo mesh extend beyond the patient incision? yes.Was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? n/a.Was the skin prep solution wiped off and let dry before applying adhesive? unknown.Was a dressing placed over the incision? if so, what type of cover dressing used? yes, mepilex standard.What date did the reaction occur on? 24-48 hours.What does the reaction look like? please provide details.¿ rash, blistering, itchiness around where dermabond was applied, even beyond the tape.How large of an area does the reaction cover? the entirety of the mesh tape and 1-3 cm beyond the perimeter of the mesh.Do you have any pictures of the reaction? yes.What was done to address the reaction? remove with vaseline, dry abd and ace wrap, steroid cream administered.What type of medication was used to treat the reaction? clobetasol.What was the dosage?.05%.When (date) was the medication administered? 3-4 days post-op.Was the product removed? was another method used to close the incision? yes.No.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? none known to cyanoacrylates or formaldehyde.Is the patient hypersensitive to pressure sensitive adhesives? yes.Were any patch or sensitivity tests performed? no.Can you identify the lot number of the product that was used? no.Patient demographics: initials / id; age or date of birth; bmi ; gender; pre-existing medical conditions (ie.Allergies, history of reactions): patient is extremely sensitive to many different adhesive products, latex allergy, cannot use any other (b)(4) besides (b)(4).
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It was reported that the patient underwent a periacetabular osteotomy/screw removal procedure on unknown date and the topical skin adhesive was applied on the skin with one layer.Chloraprep was used at the beginning of the procedure.It was also reported that cover mepilex dressing was placed over the incision.Twenty four- forty eight hours following the procedure, the patient experienced severe skin reaction, itching, blistering and rash around where topical skin adhesive was applied, even beyond the tape.The topical skin adhesive was removed with vaseline, then dry abd and ace wrap was applied.It was reported that three-four days post-op, 0.05% clobetasol steroid cream was administered.
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