Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Itching Sensation (1943); Rash (2033); Unspecified Tissue Injury (4559)
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Event Date 11/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).
Additional information has been requested however not received.
If further details are received at a later date a supplemental medwatch will be sent.
Please address the questions below to aide in our complaint investigation: what product code of prineo was used? lot number? are any photos of the patient reaction available? date of reaction? please describe how 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: age or date of birth; bmi patient pre-existing medical conditions (ie.
Allergies, history of reactions)? 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? no product to return.
This medwatch report is in response to receipt of a voluntary medwatch: mw5101164.
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Event Description
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It was reported a patient underwent a subcutaneous mastectomy on (b)(6) 2020 and topical skin adhesive was used.
On an unknown date in 2020, patient developed a papular, erythematous, pruritic rash that involved the entire extent of the wound.
Because of persistent pruritus and resultant itching and scratching, the right nipple graft was displaced on postoperative day 12 (2020).
The right nipple was sutured to the wound by surgeon, the day of the event, with preservation of vascular supply.
The wounds healed well with no further complications.
No device will be returned.
Additional information has been requested.
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Search Alerts/Recalls
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