Catalog Number CLR222US |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Skin Irritation (2076); Not Applicable (3189)
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Event Date 08/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The following additional information was requested and obtained: what does the reaction look like and how large of an area does the reaction cover? after further investigation the reaction that the doctor was experiencing was not a chemical reaction.The surgeon experienced oozing of blood and slight dehiscence.I will discuss some homeostasis products to address this issue.Do you have any pictures of the reaction? no.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.N/a what is the most current patient status? the doctor changed the patients dressing with something other than prineo.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? n/a.The following additional information has been requested but no response received to date: what date did the reaction / dehiscence occur post op? what medical / surgical treatment was provided to treat the dehiscence? what medical / surgical treatment was provided to treat the reaction? lot number? describe the reaction (e.G.Blister/red/infected/mild¿) what prep was used prior to, during or after prineo use? how many layers of adhesive were used over during application? 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? what is the physicians opinion of the contributing factors to the reaction? patient demographics: initials / id; age or date of birth; bmi, gender.Patient pre-existing medical conditions (ie.Allergies, history of reactions) was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? what was the patient outcome? 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.
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Event Description
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It was reported a patient underwent a total knee replacement procedure on (b)(6) 2019 and topical skin adhesive was used.Post operatively, the patient developed bumps and skin reaction, dehiscence and discharge from the wound.The doctor changed the patients dressing with something other than adhesive.Additional information has been requested.
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Manufacturer Narrative
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Product complaint (b)(4).The following additional information was received: after further investigation the doctor mentioned that it was not a reaction but a drainage problem he was having that is unrelated to prineo.
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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to the fda: 10/24/2019.Corrected information: b1, b2, h1 ¿ based upon the additional information received, the event no longer meets reportable serious injury criteria.Therefore, this file is now not reportable.
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Search Alerts/Recalls
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