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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erythema (1840); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943)
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| Event Date 01/28/2024 |
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Event Type
Injury
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Event Description
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It was reported a patient had total shoulder replacement surgery on (b)(6) 2024 and topical skin adhesive was used.When the bandage was removed after 6 days, it became apparent that's why he was having an allergic reaction (topical) to the product, as the area was very inflamed, red, and itchy.Within a couple days the itching was unbearable.He had seen the surgeon again and had the glue removed, to begin healing.I used some medication (rx) i had from a previous surgery called hydroxyzine.Additional information has been requested.
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Manufacturer Narrative
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Product complaint#: (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested and received.What date did the reaction occur on (dd/mm/yyyy)? the surgery was on (b)(6) 2024.The incision/glue was covered with a bandage until on (b)(6), so i'm unsure when the rash started exactly.However, when the bandage was removed, the area was very red and irritated.At that time, we (np and i) were unsure if it was just from being covered with bandage for 6 days.However, the itching started several days prior, perhaps on (b)(6)? the itchiness and redness progressively got worse each day once exposed.By on (b)(6), i was picking at the glue to try to remove it, because it was causing great discomfort.As the glue came off, my skin came off with it, and the area underneath was raw, like underneath a blister when it is ruptured.Do you have any pictures of the reaction? this was taken on (b)(6) after the bandaging was removed.I do not have a picture of it at its worst.Was there any medical or surgical intervention performed (re-operation; re-closure; prescription medication)? if so, please specify.No additional surgical invention, however on (b)(6), i went to the dr's office to get them to remove the glue, which they did with alcohol wipes.They recommended using some antibiotic strips and a bandage to cover and secure the strips.I used for <1 day, as theses were causing more itching on my already irritated skin.They also suggested applying vaseline.I did not use this.If medication was required, please clarify if it was prescribed by a physician.The orthopedist's office did not prescribe medication; however the itching and irritation was severe, such that i used some medication (rx) i had from a previous surgery called hydroxyzine.I typically have used it for itching caused by the opioids taken post-surgery.I have never had a reaction to glue prior to this.(i've had other surgical wounds sealed with glue, however i do not know the brand or type.) in addition, due to my sensitive skin and other topical allergies, i keep rx desoximetasone gel on hand for these types of flare-ups, so i used that 2-3x daily around the perimeter of the incision/glue beginning on (b)(6) 2024.This helped to some degree, but it could not penetrate into the area under the glue.Once glue was off i continued using the gel over the entire area.Can you identify the product code and lot number of the product that was used? i do not have this information from the surgery center.The center is (b)(6) surgery in (b)(6) if you want to contact them directly.What is the most current patient status? glue removed on (b)(6), affected skin is clearing up and drying out.I used the desoximetasone and hydroxyzine until on (b)(6).Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? not to my knowledge.I have had surgical glue used in 2022 (and possibly 2016, don't recall for sure on this one), but do not know brand or product.There was no reaction to that glue at that time.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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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Manufacturer Narrative
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Product complaint # (b)(4).Additional information has been requested and received.If in your possession, may we have a copy of your operative report? i do not possess a copy of the operative report.Does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? granting my permission to contact my doctor regarding only the procedure that caused the allergic reaction, i.E.Shoulder surgery performed on (b)(6) 2024.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Was any surgical intervention performed? were any cultures taken? results? please describe how was the adhesive was applied.What prep was used prior to, during or after adhesive 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? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? patient demographics: gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? product code and/or lot of product used? current patient status.What is the physician¿s opinion as to the etiology of or contributing factors to this event? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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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