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 Erythema (1840); Itching Sensation (1943); Skin Irritation (2076); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The actual device lot number associated with this event is not known.The reporter provided the following possible lot numbers: mph256, mph056, mmj779, mph208.The following additional information was requested however to date a response has not been received: please provide photos.Please provide additional event description specific to the patient.Procedure name.Initial procedure date.Please explain how the layers were closed? what date did the reaction occur post op? how was the reaction treated (product removed; reclosure; prescription steroids; antibiotics prescribed)? if so, please clarify.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? 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? lot numbers reported mph256, mph056, mmj779, mph208.Please identify specific lot number used on each patient.Do you have the product code and lot number involved ? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? patient demographics: initials / id; age or date of birth; bmi ; gender.Patient pre-existing medical conditions (ie.Allergies, history of reactions).Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? 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.

Event Description

It was reported a patient underwent a total knee surgery on an unknown date and topical skin adhesive was used.One week post-operatively, after removing the ace bandages, the patient noticed redness and blisters from the incision site outward to the rest of the knee.The patient was treated with antibiotic ointment and currently have no infections and is doing fine.No product to be returned.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).Additional information has been received: procedure date:(b)(6) 2019, tsa removal:(b)(6) 2019.It was reported that a patient underwent a surgical procedure for total knee arthroplasty on xx and prineo skin adhesive was used.The patient developed a reaction to the product about 16 days after the procedure.The pt was reported and observed to have symptoms of redness, itching and blisters to the skin directly adjacent to and around the prineo dressing the tsa was then removed.Treatment for the pt included silvaden cream.Layer of sutures closed by the provider.The angle of the knee during surgery was reported as flexed and greater than 80 degrees.Preparation before use was 2% chg wipes then night before surgery and the morning before along with chloraprep x2 used to prep the extremity in the operating room no known allergies reported for pt.With no patch sensitivity tests performed.The following additional information has been requested, to date has not been received: please clarify-4 devices used on pt? or 4 possible lots of 1 prineo?.

Manufacturer Narrative

Product complaint # (b)(4).The ace wrap is removed 2-3 days post op (not one week); the blisters have been noted as early as the first post op day.The patient was treated with antibiotic ointment and a variety of treatments have been used (oral antibiotics, oral steroids, silvadene cream, benadryl) and currently have no infection and doing fine.Blisters have resolved.The actual device batch number associated with this event is not known.The customer reports the following possible batch numbers: lot: mph056; manufacture date: 12/07/2018; expiration date: 11/30/2020.Lot: mmj779; manufacture date: 11/20/2018; expiration date: 10/31/2020.Lot: mph256; manufacture date: 12/11/2018; expiration date: 11/30/2020.In addition, a manufacturing record evaluation was performed for each lot number and no non-conformances were identified.Possible lot: mph208 is not a valid lot for dermabond prineo.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 1/6/2020.Additional information was requested and has been received: please clarify-each voluntary medwatch from (b)(6) called into the fda listed: 4 devices used on each patient with a different lot number.Is that accurate? or did these represent 4 possible lots of 1 prineo used for each patient? i did follow up with our or director and she verified that it is the latter: these represent 4 possible lots of 1 prineo used for each patient the four lot numbers that we listed were the four that we had on hand at the time of the reactions being reported.

• 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: 8778918
• MDR Text Key: 150681376
• Report Number: 2210968-2019-83901
• 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,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• 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
• Date Manufacturer Received: 12/11/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention