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

Catalog Number CLR222

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Burn(s) (1757); Cellulitis (1768); Skin Irritation (2076)

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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the procedure name and initial procedure date? how was the device applied to the incision please describe how the adhesive was applied on the tape what prep was used prior to product application? what was the location and incision size of the application? was a dressing placed over the incision? if so, what type of cover dressing used? what date did the reaction occur on? what does the reaction look like and how large of an area does the reaction cover? do you have any pictures of the reaction? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Can you identify the lot number of the product that was used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? for female patients, were they exposed to similar products, such as artificial nails? what is the most current patient status? patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.

Event Description

It was reported that a patient underwent a foot/ankle procedure on unknown date in 2017 and topical skin adhesive was used.Following the procedure the patient experienced chemical reaction which looks like a burn.An op-site sticky/ dry dressing was applied on top of the topical skin adhesive.The patient was readmitted and treated for the burn.The patient was treated for cellulitis which developed following the burn.Additional information has been requested.

• Brand Name: DERMABOND PRINEO
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876
• Manufacturer (Section G): ETHICON INC. SAN LORENZO
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876 ; 9082182792
• MDR Report Key: 6786407
• MDR Text Key: 82450188
• Report Number: 2210968-2017-70016
• Device Sequence Number: 1
• Product Code: OMD
• 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: 07/27/2017

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: CLR222
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention