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 Rash (2033); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The following additional information was requested and the following was received: please provide photos - no photos available.Initial procedure date a few weeks ago, no specific date.What date did the reaction occur post op? no specific date known.How was the reaction treated in addition to antibiotics (product removed; reoperation; reclosure; prescription steroids; prescribed)? if so, please clarify - the doctor removed the prineo, and prescribed antibiotics.Please indicate any medical or surgical interventions performed.No.Please describe how was the adhesive was applied on the tape.Applied the product to the tape, per ifu.What prep was used prior to, during or after prineo use? nothing.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 allergies.Is the patient hypersensitive to pressure sensitive adhesives? no.Were any sensitivity tests performed? no do you have the lot number involved? no.What is the physicians opinion of the contributing factors to the reaction? the cyanoacrylate caused the skin reaction.What is the most current patient status? patient is fine, no skin reactions.Is the product or representative sample (product from the same lot number) available for evaluation? no product available.Patient demographics: initials / id; age or date of birth; bmi ; gender - don't want to disclose patient information.Patient pre-existing medical conditions (ie.Allergies, history of reactions) no pre-existing medical conditions.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? no.The following additional information was requested and not yet clarified: please specify type of orthopedic procedure name? did each patient have both a hip and knee replacement? to date the device has not been returned and no additional information has been received.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported a patient underwent an orthopedic procedure on an unknown date and topical skin adhesive was used.The patient returned, two weeks post operatively, complaining of skin rash and blisters, 10 to 15 cm along the incision line.The doctor removed the adhesive.The patient was prescribed and treated with antibiotics.The current patient status is healed.Additional information was requested.

Manufacturer Narrative

(b)(4).Additional information received in response to question: please specify type of orthopedic procedure name? procedure was a total hip replacement.

• 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
• MDR Report Key: 8861033
• MDR Text Key: 153273911
• Report Number: 2210968-2019-85162
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 09/03/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention