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(b)(4).
A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional information received: what is the most current patient status? progressed to resolution but still experienced marked scaring.
Patient pre-existing medical conditions (ie.
Allergies, history of reactions).
Patient has strong history of allergic reactions to chlorhexidine, penicillin, tetanus, msaids and bandages.
What is the physicians opinion of the contributing factors to the reaction? surgeon believes to be a prineo reaction.
Attempts have been made to obtain the following additional information, however not received to date: t was noted that antibiotics were prescribed and readmitted for wound management, was the reaction treated in any other manner (product removed; reoperation; reclosure; other prescription)? if so, please clarify.
Please indicate any medical or surgical interventions performed.
Please describe how was the adhesive was 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? attempts have been made to obtain additional information.
To date the device has not been returned and no additional information has been received.
If the device or further details are received at a later date a supplemental medwatch will be sent.
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It was reported a patient underwent a total knee replacement on (b)(6) 2019 and topical skin adhesive was used.
On post op day 3, patient presented with marked skin reaction at the surgical site: inflammation, blisters, bruising and wound discharge.
Was re-admitted to hospital for antibiotics and manage wound and reduce surgical site infection risk.
Progressed to resolution but still experienced marked scaring.
Additional information was requested.
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