MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).The following information has been requested but not received.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Procedure name? date of procedure? date of reaction? what was the patient¿s medical history/comorbidities? were there any other post-operative surgical complications than the alleged reaction? 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: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions).Does the patient use or 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?.

Event Description

It was reported a patient underwent an unknown procedure on an unknown date in 2020 and topical skin adhesive with mesh was used.The patient had a systemic reaction which resulted in an additional five nights in hospital.Patient given a steroid cream and antihistamines as a treatment.Additional information has been requested.

Manufacturer Narrative

Product complaint #(b)(4).Date sent to the fda: 11/18/2020 additional information: a1, a2, a3, b6, b7 corrected information: b3 the following information has been requested and received.¿ noted that patient were given a steroid creams and antihistamines as a treatment is this the only treatment given? did the patient have to be taken back to theatre for any further treatment/surgery? patient was readmitted to (b)(6) hospital on the (b)(6) 2020.She did not require any further surgery.She was referred to a general physician for review who in turn referred her to a dermatologist for review and further management.Physician reviewed pt and noted that ¿she had a severe rash around her knee spreading to the rest of her body( sparing the face mucosae and the palms & soles)¿ he prescribed her 2 doses of prednisolone 50mgs on day one and day two.Also started her on loratadine 20mgs tds for the itch and diprosone 0.05% cream he then referred her to a dermatologist who noted ¿ widespread symmetrical pruritic eczematous eruption which was predominantly flexural.There was a area over her left knee which corresponded to the wound dressing¿ histology of a punch biopsy taken from her abdomen ¿ results¿ supports diagnosis local allergic reaction dermatitis.For soap free wash, regular emollient & weaning regimen of topical steroids ¿ for the 5 additional night stays was that solely due to the reaction reported? yes ¿ procedure name? our pt had a left total knee replacement ¿ date of procedure? (b)(6) 2020 ¿ date of reaction? first notified of reaction on the (b)(6) 2020 from a telephone consult with home support services ( nursing service visiting pt to change review wound dressing) ¿ what was the patient¿s medical history/comorbidities? ¿ diabetes, hypertension, hypercholesterolaemia, gord , sleep apnoea ¿ were there any other post-operative surgical complications than the alleged reaction? deranged lfts ( bloods) 1st day post op, below knee deep vein thrombus found day 4 post op ¿ please describe how was the adhesive was applied.As per protocol ¿ what prep was used prior to, during or after prineo use? skin was prepared for surgery using a alcohol/ chlorhexidine skin prep ,unsure if any further skin cleaning was undertaken ¿ was a dressing placed over the incision? if so, what type of cover dressing used? dermabond prineo was primary dressing, then a post op visible dressing ( secondary dressing- brand smith & nephew) was placed over the dermabond prineo ¿ is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? not known ¿ is the patient hypersensitive to pressure sensitive adhesives? not known ¿ were any patch or sensitivity tests performed? no ¿ patient demographics: initials / id, gender, age or date of birth; bmi gs, f, 67, dob (b)(6)1953, bmi 39 ¿ patient pre-existing medical conditions (ie.Allergies, history of reactions) multiple allergies- diclofenac ¿ gi irritation, amlodipine - moderate leg oedema, chloramphenicol- severe rash, norspan- severe constipation, predneferin forted eye drops- moderate rash, contrast medium?? ¿ does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails) not known ¿ was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? not to my knowledge 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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10646260
• MDR Text Key: 210406082
• Report Number: 2210968-2020-07766
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR