Product complaint #: (b)(4).Date sent to fda: 3/1/2021.Additional information was requested and the following was obtained.If further details are received at a later date a supplemental medwatch will be sent.Name of orthopedic procedure performed? date of procedure? date of reaction? is a photo available of the reaction? it was noted that a prescription steroids were given.Were there any other medical or surgical interventions performed? please describe how the adhesive was applied.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? patient demographics: initials / id, gender, age or date of birth; bmi.Patient pre-existing medical conditions (ie.Allergies, history of reactions).Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails).Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? can you identify the product lot number of the product that was used? what is the current status of the patient? product will not be returned.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Product complaint # (b)(4).Date sent to the fda: 4/12/2021.Additional information was requested, and the following was obtained.If further details are received at a later date a supplemental medwatch will be sent.Name of orthopedic procedure performed? total knee arthroscopy.Date of procedure? around (b)(6) 2021 (not exact).Date of reaction? week of (b)(6) 2021.Is a photo available of the reaction? yes.It was noted that a prescription steroids were given.Were there any other medical or surgical interventions performed? n/a.Please describe how the adhesive was applied.The adhesive was applied in a fully flexed position, while wiping off any excess.What prep was used prior to, during or after prineo use? nothing has changed with before or after use.Was a dressing placed over the incision? if so, what type of cover dressing used? yes, guaze and tegaderm.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? n/a.Is the patient hypersensitive to pressure sensitive adhesives? n/a.Were any patch or sensitivity tests performed? n/a.Patient demographics: initials / id, gender, age or date of birth; bmi.N/a.Patient pre-existing medical conditions (ie.Allergies, history of reactions).N/a.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails).N/a.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? n/a.Can you identify the product lot number of the product that was used? n/a.What is the current status of the patient? patient fully recovered.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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