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

Catalog Number CLR222US

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Skin Discoloration (2074); Skin Irritation (2076); No Code Available (3191)

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. Location and size of the initial scar? 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? what is the physicians opinion of the contributing factors to the reaction? does the physician believe that the hyperpigmentation around the scar is related to the prineo? what is the most current patient status? patient demographics: initials / id; age or date of birth; bmi ; gender? patient pre-existing medical conditions (ie. Allergies, history of reactions)? was prineo/"demabond" or skin adhesive used on the patient in a previous surgery or wound closure?.

Event Description

A patient underwent a scar revision procedure on (b)(6) 2018 and topical skin adhesive was used. On (b)(6) 2018 the patient was diagnosed with contact dermatitis. The patient experienced an erythematous rash along the scar with blisters (2 cm wide). The patient was treated by removing the product and topical corticoids were applied daily for two weeks. The patient currently has hyperpigmentation around the scar. Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM SKIN CLOSURE
• 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; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8289598
• MDR Text Key: 134495611
• Report Number: 2210968-2019-78628
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: SG
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/30/2019 Patient Sequence Number: 1