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 Rash (2033); Local Reaction (2035)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: (b)(4) the surgeon has been using this product for the last two years.Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Procedure name? procedure date? what was the date of the reaction, day post op? it was described that ¿the area was treated with antibiotics and steroids¿.Were these prescription strengths for each patient? what other medical and or surgical intervention was provided to address the issue? 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 has the patient previously been 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.Is there a photo available of the patient¿s reaction (please reference pt/pc)? no device available for analysis.Note: events reported on mw# 2210968-2021-07795, mw# 2210968-2021-07796, mw# 2210968-2021-07797, mw# 2210968-2021-07798, mw# 2210968-2021-07799, mw# 2210968-2021-07800, mw# 2210968-2021-07801, mw# 2210968-2021-07808, mw# 2210968-2021-07803, mw# 2210968-2021-07804, and mw# 2210968-2021-07806.

Event Description

It was reported a patient underwent an unknown orthopedic procedure on a unknown date and topical skin adhesive was used.Patient presented with a red raised red rash on the entire area where the adhesive was applied to the outer edge.Patient has no history of allergic reactions to adhesives.The area was treated with antibiotics and steroids.The reaction was within three days of application.Additional information has been requested.

• 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
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12387784
• MDR Text Key: 268802443
• Report Number: 2210968-2021-07807
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• 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
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention