MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222US

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

Patient Problems Inflammation (1932); Skin Irritation (2076); Not Applicable (3189)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information was requested, however not received.To date the device has not been returned.If further details are received at a later date a supplemental medwatch will be sent.Date of tkr? confirm (b)(6) 2020 was the date of reaction? it was noted that surgical intervention was provided to remove the prineo.Please detail what was done and any treatment provided (reoperation; reclosure; prescriptions; antibiotics prescribed) to address reaction? please indicate any medical or surgical interventions performed.Please describe how was the adhesive was applied.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? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? patient demographics: initials / id; age or date of birth; bmi ; patient pre-existing medical conditions (ie.Allergies, history of reactions) does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails).Current patient condition? has this patient been exposed to prineo/dermabond in a previous procedure? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported a patient underwent a total knee replacement on and unknown date and surgical sealant was used.Post operatively, the patient came back with an inflamed wound.Patient wasn't known to have any allergies.They are taking the patient to the or to remove the adhesive.No device will be returned.Additional information has been requested.

Manufacturer Narrative

Product complaint#: (b)(4).Date sent to the fda: 8/3/2020.Additional information: concomitant product: stratafix unknown.The following information was requested, and the following was obtained.To date the device has not been returned.If further details are received at a later date a supplemental medwatch will be sent.Date of tkr? on (b)(6) 2020.Confirm on (b)(6) 2020 was the date of reaction? surgery on (b)(6), reported back to or on (b)(6).Reaction took place in between that time.Please detail what was done and any treatment provided (reoperation; reclosure; prescriptions; antibiotics prescribed) to address reaction? on (b)(6) 2020 ¿to my office.Concerned about possible dehiscence and joint involvement so scheduled for dressing change and possible irrigation / debridement in or.¿ on (b)(6) 2020 or ¿prineo peeled off easily using petroleum jelly.Wound was well approximated and no debridement needed.Dressed with bulky circumferential dressing.¿ please describe how was the adhesive was applied.Applied in flexed knee position and exactly according to ifu.Was a dressing placed over the incision? if so, what type of cover dressing used? (mepilex).What prep was used prior to, during or after prineo use? prepped with chloraprep, dermabond prineo, mepilex is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? yes.Is the patient hypersensitive to pressure sensitive adhesives? ¿allergy appointment.Dx w previous sensitization (on (b)(6) 2020) to adhesive agent (2-octyl cyanoacrylate) with allergic contact dermatitis (on (b)(6) 2020).Dermabond listed as new allergy.¿ were any patch or sensitivity tests performed? yes, patient demographics: initials / id; age or date of birth; bmi ; 54 y/ o white female patient pre-existing medical conditions (ie.Allergies, history of reactions) prior to reaction, none.Does the patient use or exposed to similar glues / agents for repair, crafts, cosmetic use (lashes, nails).Unknown.Current patient condition? recovering.Has this patient been exposed to prineo / dermabond in a previous procedure? yes, dermabond advanced.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10263868
• MDR Text Key: 198513934
• Report Number: 2210968-2020-05239
• 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: 06/30/2020

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 Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 08/03/2020
• Patient Sequence Number: 1
• Treatment: STRATAFIX UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR