Catalog Number CLR222US |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Skin Irritation (2076); No Code Available (3191)
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Event Date 02/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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(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.Please provide photos.Procedure name.Initial procedure date.What date did the reaction occur post op? how was the dermatitis treated (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? if so, please clarify 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? was the site cultured? if so, what bacteria were identified? 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? do you have the lot number involved ? what is the physicians opinion of the contributing factors to the dermatitis? 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).For female patients ask: was the patient exposed to similar products, such as artificial nails.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?.
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Event Description
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It was reported that the patient underwent a chest procedure on (b)(6) 2018 and topical skin adhesive was used.The patient developed dermatitis.The dermatitis appeared only on the area to which the topical skin adhesive had been applied.The patient had medical examination at the department of dermatology.After treatment we couldn¿t get details at dermatology, the patient recovered and was discharged from the hospital.Additional information has been requested.
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Manufacturer Narrative
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Product complaint # pc-000130375 additional information was requested and the following was obtained: "please provide photos => we have no photos.Procedure name => video-assisted thoracic lung lobectomy.Initial procedure date =>(b)(6) 2018 what date did the reaction occur post op? => pod1 how was the dermatitis treated (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? => no information.If so, please clarify => na.Please describe how was the adhesive applied on the tape => no information.What prep was used prior to, during or after prineo use? => no information.Was a dressing placed over the incision? => no information.If so, what type of cover dressing used? => n/a.Was the site cultured? => no information.If so, what bacteria were identified? => n/a.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? => no information.Is the patient hypersensitive to pressure sensitive adhesives? => no information.Were any patch or sensitivity tests performed? => no.Do you have the lot number involved ? => not available.What is the physicians opinion of the contributing factors to the dermatitis? => no information.What is the most current patient status? => the patient has recovered, and has been discharged from the hospital.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 ; gender patient pre-existing medical conditions (ie.Allergies, history of reactions) => no information.For female patients ask: was the patient exposed to similar products, such as artificial nails => no information.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? =>no information.".
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Search Alerts/Recalls
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