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(b)(4).
The following information was requested and obtained.
If the further details are received at a later date a supplemental medwatch will be sent.
Date of surgery? (b)(6) 2020.
Date of wound dehiscence/surgical intervention? (b)(6) 2020.
Was there any other treatment provided (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed) ? if so, please clarify.
Once wound dehiscence was noted a mepilex was placed over the prineo dressing and the patient was scheduled for a wound irrigation and debridement with closure on the evening of (b)(6) 2020.
Please indicate specific medical or surgical interventions performed.
Original surgery was a primary total knee arthroplasty, second surgery performed was an irrigation and debridement with closure, as a result of the wound dehiscence were any anomalies/damage noted with the product prior to use? none reported.
Please describe how was the adhesive was applied.
On a dry, hemostatic surface, in flexed position, after closure of capsule, subcutaneous, and subcuticular layers.
What prep was used prior to, during or after prineo use? chloraprep as surgical prep (but was wiped with saline lap and dried off).
Was a dressing placed over the incision? if so, what type of cover dressing used? dry gauze-abd pads and ace wrap were placed over dressing in the operating room, floor nurse placed mepilex over dressing when wound dehiscence was noted.
What is the physicians opinion of the contributing factors to the wound dehiscence? the surgeon felt like maybe the patient might have had a partial fall or done something to cause increased stress to the sutures to cause a dehiscence.
He felt his closure was strong and was surprised that it had come apart.
What is the most current patient status? unknown at this time.
Is the product lot number available? qcbhjh.
Patient demographics: initials / id - (b)(6); age or date of birth-(b)(6); gender-f; bmi-26.
33.
Was there any patient precipitating factors that lead to the wound dehiscence (ex.
Fall, strenuous exercise, etc.
)? nothing that was noted, surgeon did question if something had happened that would have caused extra stress on the sutures.
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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It was reported a patient underwent a total knee arthroplasty on (b)(6) 2020 and surgical sealant was used.
Post operatively, the wound dehisced.
The patient had a second surgery performed, irrigation and debridement with closure, as a result of the wound dehiscence no other information is available.
No device will be returned.
Additional information requested.
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