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

Model Number CLR222

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

Patient Problem Rash (2033)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional narrative from surgeon: the surgeon also informed representative that he has been using medtronic suture (biosyn) during this time and has had wound complications he feels is related to this suture (dehiscence and infection).Additional information has been requested however, not received.If further details are received at a later date a supplemental medwatch will be sent.2 photos were received.Are the photos of 1 patient or more? which file corresponds to each photo? procedure name? procedure date? what was the date of the reaction, day post op? 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: id, gender, age or date of birth; bmi.Does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails).Was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? do you have the product code and /or lot number used? current patient status.No product is available for return.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 an adolescent patient underwent an orthopedic procedure on an unknown date and topical skin adhesive was used.Patient returned with a rash in the area adhesive was used.Rash treated with steroids.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 9/14/2021.Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent 2 photos were received.Are the photos of 1 patient or more? which file corresponds to each photo? - photos are of two separate patients; unknown which file corresponds to each photo procedure name? - unknown.Procedure date? - unknown.What was the date of the reaction, day post op? - unknown.Please describe how was the adhesive was applied.- unknown.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? - 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? - unknown.Patient demographics: id, gender, age or date of birth; bmi - unknown.Does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails) - unknown.Was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? - unknown.Do you have the product code and /or lot number used? - no.Current patient status.- unknown.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 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12333746
• MDR Text Key: 267046311
• Report Number: 2210968-2021-07420
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Patient Sequence Number: 1
• Treatment: BIOSYN / MEDTRONIC
• Patient Outcome(s): Required Intervention