MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE; CUTANEOUS TISSUE ADHESIVE WITH MESH

Catalog Number CLR422

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

Patient Problems Local Reaction (2035); Blister (4537)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information has been requested and obtained.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.What is the procedure date? unknown.What date did the reaction occur on? unknown.What does the reaction look like and how large of an area does the reaction cover? described as blistering along prineo and under mesh.Do you have any pictures of the reaction? no.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Surgeon said removed prineo and ox¿d prophylactic antibiotics what is the most current patient status? stable.Can you identify the lot number of the product that was used? no.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.The following information has been requested however not received.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.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, gender, 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).Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? can you identify the lot number of the product that was used? current patient status.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 an unknown date in 2020 and topical skin adhesive with mesh was used.The patient experienced a skin reaction with blisters.The product was removed and patient prescribed prophylactic antibiotics.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: 12/30/2020.The following information has been requested and the obtained.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Please describe how was the adhesive was applied.Per ifu.What prep was used prior to, during or after prineo use? 3m soluprep swab.Was a dressing placed over the incision? if so, what type of cover dressing used? unknown.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Were any patch or sensitivity tests performed? no.Patient demographics: initials / id, gender, age or date of birth; bmi unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions) unknown.Does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails) unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.Can you identify the lot number of the product that was used? not available.Current patient status.Stable.No further information is forthcoming from site or surgeon - requested but no response.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 42CM MSH 3.8ML ADHESIVE
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11010330
• MDR Text Key: 221500286
• Report Number: 2210968-2020-09924
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• PMA/PMN Number: K163645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

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 Catalogue Number: CLR422
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 12/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention