Product complaint # (b)(4).
Device not returned.
Additional information has been requested and obtained.
If further details are received at a later date a supplemental medwatch will be sent.
Do you have a photo of your reaction? yes.
Please provide the confirm the date of surgery was (b)(6) 2021.
Date of surgery (b)(6) 2021.
Was any surgical intervention provided, please describe? no surgical intervention for reaction.
Product removed w/txn with steroid cream clobetasol propionate.
05% around wound.
Were you treated with prescription medications (not over the counter) please describe? claritin redi tabs purchased otc 1 qd prescribed of no benefit and stopped after 3 days.
Steroid ointment rx clobetasol propionate.
05% applied around wound after dermabond prineo was removed additional information was requested however not received.
If further details are received at a later date a supplemental medwatch will be sent.
What medical and/or surgical intervention was performed to address the wound dehiscence and /or reaction? please describe how was the adhesive was applied? please describe how was 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: id, age or date of birth; bmi.
Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? do you have the product code and/or lot number used? current patient status.
No product is available for return.
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 hip replacement on (b)(6) 2021 and topical skin adhesive was used.
Twenty-four hours after patient developed irritation, redness and itching on the wound where the product was applied.
There is also a yellow substance draining out of the wound.
The area above the wound all the way up to the patients breast is splotchy.
The patient is taking claritin to help with the symptoms.
Product removed with steroid cream clobetasol propionate.
05% around wound.
Also, there is some bleeding coming from partially open spots on the wound.
Additional information has been requested.
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