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

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Reaction (2414); No Code Available (3191)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What characteristics prompted the physician to believe that the patient had allergic reaction to the prineo? please explain the reason that patient was brought back to or to have the prineo removed? please explain any medical or surgical interventions performed? please provide photos.What date did the reaction occur post op? how was the reaction treated (prescription steroids; antibiotics prescribed)? what was the angle of the knee during application? please describe how was the adhesive applied on the tape.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? were any patch or sensitivity tests performed? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender.Patient pre-existing medical conditions (ie.Allergies, history of reactions).For female patients ask: was the patient exposed to similar products, such as artificial nails was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.

Event Description

It was reported that a patient underwent a total knee replacement procedure on (b)(6) 2017 and topical skin adhesive was used.The patient experienced an allergic reaction to the topical skin adhesive.The patient was brought back to the or to remove the topical skin adhesive and wound dressings were placed.Additional information has been requested.

Manufacturer Narrative

Corrected narrative: it was reported that a patient underwent a hip surgery procedure on (b)(6) 2017 and topical skin adhesive was used.Two days post operatively, the patient had an allergic reaction with a large red rash where the topical skin adhesive had been applied.The patient was brought back to or for cleaning with normal saline and antihistamines, incision and debridement, drainage, head and liner exchange, and to remove the topical skin adhesive and then closed with suture.The physician opines that the patient has hypersensitivity to topical skin adhesive.The patient is currently doing well and is healed fully.Corrected patient codes: (b)(4) - medical intervention, (b)(4) - surgical intervention device code: (b)(4) ¿ reaction occurred additional information: additional information was requested and the following was obtained: what characteristics prompted the physician to believe that the patient had allergic reaction to the prineo? large red rash only where the prineo had been applied please explain the reason that patient was brought back to or to have the prineo removed? drainage from rash caused by the prineo and around the incision please explain any medical or surgical interventions performed? incision and debridement, head and liner exchange, closure with nylon what date did the reaction occur post op? 2 days postop how was the reaction treated (prescription steroids; antibiotics prescribed)? treated with take back to or for cleaning with normal saline, and antihistamines what was the angle of the knee during application? it was a hip please describe how was the adhesive applied on the tape - standard sheet what prep was used prior to, during or after prineo use? only prior, chloroprep was a dressing placed over the incision? if so, what type of cover dressing used? no dressing is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no were any patch or sensitivity tests performed? no what is the physicians opinion of the contributing factors to the reaction? hypersensitivity to the prineo what is the most current patient status? well, healed fully is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender - mh, 82 patient pre-existing medical conditions (ie.Allergies, history of reactions)- none for female patients ask: was the patient exposed to similar products, such as artificial nails - unknown was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6774597
• MDR Text Key: 82069563
• Report Number: 2210968-2017-33390
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR