Catalog Number CLR602 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Wound Dehiscence (1154); Erythema (1840); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Rash (2033); Swelling (2091); Burning Sensation (2146); Impaired Healing (2378); Reaction (2414); No Code Available (3191)
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Event Date 06/23/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Event Description
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It was reported that the patient underwent an unknown procedure on unknown date and a topical skin adhesive was used.The patient was advised to use octenisan as a lotion/shower gel before and after surgery.After the procedure, the patient experienced a pain, severe reaction and swelling, and was developing a large rash around the area of application to a much wider extent than the original area, where topical skin adhesive was applied.The patient had to be readmitted to hospital and has had further treatment.Additional information has been requested.
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Manufacturer Narrative
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Date sent to the fda: 07/28/2016.(b)(4).Additional information was requested and the following was obtained: underwent abdominoplasty on (b)(6) 2016.Following surgery the pt awoke in the recovery area complaining of severe, burning abdominal pain.During the first week post-op she experienced worsening redness and itching around her wound and down her legs.She was discharged home on (b)(6) and readmitted to hospital the following day because of her symptoms.The scar appeared very angry and was blistered, but the wound remained intact.The prineo was removed.She was commenced on hydrocortisone, prednisolone and fucidin.A wound swab was taken on (b)(6) and there was growth of staph aureus and pseudomonas, so ciprofloxacin and flucloxacillin were commenced.An ultrasound scan of the wound was also performed and revealed no abnormalities.The pt was last reviewed on (b)(6) and things seems to be settling down slowly, although there is slight dehiscence of certain parts of the wound (not requiring any intervention at this time).
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Manufacturer Narrative
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Date sent to fda: 11/4/2016.Additional information: age/date of birth, weight, other relevant history.Additional (b)(4).Additional information was requested and the following was obtained: procedure name - abdominoplasty.Procedure date ¿ on (b)(6) 2016.Location and incision size of product application? abdomen.What prep was used prior to prineo use? chlorhexidine, alcohol betadine.Was the prep allowed to dry prior to prineo mesh application? yes, savalon dry applied.Please describe how the adhesive was applied on the tape? in accordance to protocol.When applying are they completely covering the edge of the mesh with prineo? yes.Was the mesh placed over the entire length of the incision? yes.Did the prineo mesh extend beyond the patient incision? yes.Was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? yes, savalon.Was the skin prep solution wiped off and allowed to dry before applying adhesive? yes.Was a dressing placed over the incision? if so, what type of cover dressing used? gauze, no tape.Date of reaction ¿ (b)(6) 2016.What does the reaction look like? please provide details.¿ red rash, small blisters.How large of an area does the reaction cover? along scar line above & below tracking down towards legs at either end.Did the skin reaction extend beyond the borders of the tape- yes.Do you have any pictures of the reaction? yes.What was done to address the reaction? hospital re-admission, iv hydrocortisone bd followed by prednisolone 50 mg.What type of medication? dose? when (date) administered? prednisolone 40 mg.Was the product removed? was another method used to close the incision? yes, removed, no other closure used.Was the site cultured? if so, what bacteria were identified? yes, pseudomonas & staphylococcus aureus.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no.Is the patient hypersensitive to pressure sensitive adhesives? elastoplast; doxycycline; lanolin; water on skin-urticaria rash.Were any patch or sensitivity tests performed? no.What is the physicians opinion of the contributing factors to the reaction? prineo tape.What is the most current patient status? ongoing.Is the product or representative sample (product from the same lot number) available for evaluation? given to company representative.Patient demographics: initials / id; age or date of birth; bmi ; gender ¿ (b)(6) female.Patient pre-existing medical conditions (ie.Allergies, history of reactions)- elastoplast; doxycycline; lanolin; water on skin=urticaria rash.For female patients : was the patient exposed to similar products, such as artificial nails- no.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? dermabond not prineo used in past for facelift 3 weeks after glue removed rash started thought it was lanlolin.
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Manufacturer Narrative
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(b)(4).The following additional information was received: the first reaction the patient had was immediately after surgery on (b)(6) 2016, when the patient woke from the anaesthetic screaming from the intense burning pain along the incision line.The anaesthetist gave the patient something that settled the worst of the pain, but the patient reported there was always discomfort from itching and burning.By the following morning of (b)(6) 2016, the patient had swollen so much that the pant legs of the garment had cut into the patient causing bad bruising to the groin area.The garment had to be changed for a larger size and padded dressings tucked into the legs.The hook and eye closures also had to be left undone because the area was so swollen that despite the bigger size, it was still cutting into the patient.The actual blisters were first noticed on (b)(6) 2016 when the dressings and garment were removed during a check up before the patient went home.The patient was prescribed daktacort ointment and given antihistamines to go home with.The patient was then readmitted on (b)(6) 2016 with all the other symptoms.The patient reported they are still erupting in blisters and sores on the back, shoulders, arms, legs, hands, face and feet.They are intensely itchy and will not heal.
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Search Alerts/Recalls
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