MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035); Blister (4537)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.It was noted that medication was prescribed, were there any other medical or surgical interventions performed? please describe how 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, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails) was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? can you identify the product code and lot number of the product that was used? what is the current status of the patient? informed the product will not be returned.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 knee replacement on (b)(6) 2021 and topical skin adhesive with mesh was used.Patient reaction noticed on (b)(6) 2021.Blisters formed, got worse and spread.Mesh was removed (b)(6) 2021, treatment of benadryl, oral and topical cream used.Reaction continued to get worse.On (b)(6) 2021 prescribed prednisone and lorazepam.Additional information has been requested.

Manufacturer Narrative

Product complaint (b)(4).Date sent to fda.Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent it was noted that medication was prescribed, were there any other medical or surgical interventions performed? only a couple rounds of prescriptions (drugs and ointments) please describe how the adhesive was applied.I am not the clinician, but the adhesive was applied across the incision with the mesh overlayed on top of that.What prep was used prior to, during or after prineo use? unknown.Was a dressing placed over the incision? if so, what type of cover dressing used? do not remember if there was any guaze, but there was an ace bandage wrapped around it.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? the patient is not hypersensitive and had a previous back surgery where dermabond was used without the mesh and had no reaction.Is the patient hypersensitive to pressure sensitive adhesives? no.Were any patch or sensitivity tests performed? no, but the patient has seen a dermatologist and is going to see an allergist.Patient demographics: initials / id, gender, age or date of birth; (b)(6), male, age 60, dob (b)(6) 1960.Patient pre-existing medical conditions (ie.Allergies, history of reactions) none.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails) only as stated as used in prior surgery.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? yes as described above.Can you identify the product code and lot number of the product that was used? no.What is the current status of the patient? the symptoms have are reduced to a few bumps and itches as of today.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: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11363222
• MDR Text Key: 238596943
• Report Number: 2210968-2021-01687
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR