MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE; SURGICAL SEALANT

Catalog Number CLR222US

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

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.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.Additional information was requested and the following was obtained: how was the reaction treated? patient presented to the ed with rash and intense itching throughout the body.Admitted to the pediatric unit and steroids given.What prep was used prior to, during or after prineo use? standard surgical prep.Was a dressing placed over the incision? if so, what type of cover dressing used? prineo then gauze placed and then long leg fiberglass cast applied.Was the site cultured? yes, upon admission both rash had blood cultures.Blood cultures were negative, rash cultures showed "staphyloccus" aureus.Is the patient hypersensitive to pressure sensitive adhesives? none noted.Were any patch or sensitivity tests performed? none.Do you have the lot number involved ¿ operating room may have that information.What is the physicians opinion of the contributing factors to the reaction? no rash was seen at the time of cast removal 2 weeks after surgery, rash developed after cast removed.What is the most current patient status? still on po steroids, mom states there has been marginal improvement.Is the product or representative sample (product from the same lot number) available for evaluation? check with operating room staff.Family did not keep any that was removed from the wound.Patient demographics: id (b)(6), dob (b)(6), ht 138 cm, wt (b)(6), female.Patient pre-existing medical conditions (ie.Allergies, history of reactions): no history of allergies, nkda.Was prineo/"demabond" or skin adhesive used on the patient in a previous surgery or wound closure? procedure name? medial proximal tibial plateau osteotomy.Internal fixation with plate.Was the cast placed during the initial surgery? post operative splint in place for two weeks.Fiberglass cat placed cast removed 2 weeks post op.Cast was taken off less than a week due after applied to pain.Date that the cast was placed? fiber glass cast put on (b)(6).Patient returned (b)(6) complaining of pain.Cast taken off complaining of pain.Was the prineo mesh removed prior to putting on cast? prineo was not removed prior to putting on the cast.Date that prineo was removed? mom did this at home.It was on at (b)(6).Taken off somewhere between (b)(6) and (b)(6).Please provide photos.

Event Description

It was reported that the patient underwent an orthopedic procedure on (b)(6) 2018 and topical skin adhesive was used.Post op splint in place for two weeks.Fiberglass cast placed (b)(6).The cast was removed (b)(6).The patient presented to the hospital on (b)(6) with rash and intense itching throughout the body.The patient was admitted, and steroids were administered.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM SKIN CLOSURE
• 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; road 183, km. 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8077714
• MDR Text Key: 127371942
• Report Number: 2210968-2018-77192
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Weight: 40