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

Catalog Number CLR222

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 04/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: what is the procedure name and initial procedure date? incision of recurrent breast cancer (b)(6) 2018.How was the prineo applied on the mesh? as per instructions for use.What prep was used prior to product application? betadine.What was the location and incision size of the application? axilla - 8cm.Was a dressing placed over the incision? if so, what type of cover dressing used? no.What date did the reaction occur on? (b)(6) 2018.What does the reaction look like and how large of an area does the reaction cover? - unknown - was not viewed by surgeon.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.Oral steroids and antihistamines.Can you identify the lot number of the product that was used? no.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.What is the most current patient status? satisfactory.Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) - female patient, no pre-existing medical conditions.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.No.

Event Description

It was reported that a female patient underwent an incision of recurrent breast cancer surgery on (b)(6) 2018 and topical skin adhesive was used.On (b)(6) 2018 the patient developed a reaction and on (b)(6) 2018 the patient presented to the ed with a rash.The patient was treated with oral steroids and antihistamines.The most current patient status is satisfactory.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC. SAN LORENZO; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7474721
• MDR Text Key: 106950407
• Report Number: 2210968-2018-72471
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2018
• 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