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 Hypersensitivity/Allergic reaction (1907); Skin Discoloration (2074); Tissue Damage (2104)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following additional information was requested and received: the information provided indicates that the surgeon attributed the allergy and blister to the prineo dressing.Please explain is there any complaint regarding the stratafix suture? no complaint to stratafix.Incision healed, only complained about redness and blisters from dermabond prineo.Does the surgeon believe that the stratafix caused or contributed to the patient allergic reaction and blistering? no.What was the angle of the knee during application? full flexion of knee.Please describe how was the adhesive applied on the tape adhesive applied on the tape? the polyester mesh of the dermabond prineo skin closure system was first applied to the clean and dry incision at full flexion ensuring the skin on each part of the incision touched each other to ensure full healing.Next the pen applicator containing the 2-octylcyanoacrylate was activated and the entire mesh was covered with the 2-octylcyanoacrylate in a single consistent layer.The mesh was allowed to dry in 90 secs before they cover with mepilex border post-op dressing (10 x 20xm).What prep was used prior to, during or after prineo use? prior to prineo used chlorhexidine, allowed to dry with dry gauze before prineo.After prineo ¿ cover with mepilex border post-op dressing (10 x 20xm) before they compression bandage the knee.Was a dressing placed over the incision? if so, what type of cover dressing used? mepilex border post-op dressing (10 x 20xm).Was the site cultured? if so, what bacteria were identified? no.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Not reported that patient had reported allergies.Is the patient hypersensitive to pressure sensitive adhesives? no.Were any patch or sensitivity tests performed? no.Do you have the lot number of clr222? no.What is the physicians opinion of the contributing factors to the reaction? dermabond prineo caused the allergy.What is the most current patient status? redness went away after 5 days, blisters got better with whole incision hyperpigmented.(b)(6) 2019, friday.Patient demographics: age and gender not sure.Asian and old.Patient pre-existing medical conditions (ie.Allergies, history of reactions) not sure as mentioned above.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? no.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 replacement procedure on an (b)(6) 2019 and topical skin adhesive was used.Patient had allergy and blistering after using adhesive as closure and wound dressing.The redness and allergy mainly resides along the shape beneath the adhesive dressing.After adhesive dressing was peeled off post-op day (pod) 12 upon patient return to clinic, blisters beneath the mesh were noticed.Surgeon attributed the allergy and blister to the adhesive dressing.Topical steroids were administered.Additional information was 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 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8772882
• MDR Text Key: 150524230
• Report Number: 2210968-2019-83812
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• 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: 06/12/2019
• 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