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

Model Number CLR222US

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

Patient Problem Rash (2033)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #(b)(4).(b)(4).Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.What was the procedure date? (b)(6), they called me two weeks postop to report so not exactly sure of the date.What date /day post op was the reaction noted? two weeks after surgery in clinic.Please describe how was the adhesive was applied.Adhesive was applied to the mesh and excess liquid was wiped away using a sterile gauze sponge.What prep was used prior to, during or after adhesive use? do not know.Was a dressing placed over the incision? no.If so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? unknown.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)? unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no.Product lot of product used? unknown.Current patient status.What is the physician¿s opinion as to the etiology of or contributing factors to this event? patient was prescribed oral and topical steroids and is recovering.Surgeon is of the opinion that our formulation has somehow changed.No product is available for return.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, or its employees that the report constitutes an admission that the product, ethicon, 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.

Event Description

It was reported a patient underwent a total hip replacement procedure on an unknown date in (b)(6) 2022 and topical skin adhesive was used.Post op, patient presented with a red raised rash under and surrounding the adhesive mesh.Doctor removed the adhesive and prescribed topical and oral steroid treatment.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: b7 additional information obtained phone call: surgeon advised, physician assistant applies prineo to his patients.Wound is prepped with duraprep -remove ioban.Uses dry sponge to dry, not wet lap or any other substance, applies adhesive use finger to spread around.Yes, 2nd exposure to adhesive.No reaction upon 1st use.If further details are received at a later date a supplemental medwatch will be sent.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, or its employees that the report constitutes an admission that the product, ethicon, 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 ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15450394
• MDR Text Key: 300210134
• Report Number: 2210968-2022-07689
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention