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

Catalog Number CLR222US

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

Patient Problems Inflammation (1932); Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). Additional information was requested and the following was obtained: please provide photos of the rash/ reaction. No photos provided. Procedure name- plastic surgery. Initial procedure date- not known. Please indicate any medical / surgical intervention performed (reoperation)? none known. Please describe how was the adhesive applied on the tape- per ifu. What prep was used prior to, during or after prineo use? not known. Was a dressing placed over the incision? if so, what type of cover dressing used? not known. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? not known. Is the patient hypersensitive to pressure sensitive adhesives? not known. Were any patch or sensitivity tests performed? not known. Do you have the lot number involved ? no. What is the physicians opinion of the contributing factors to the reaction? she suspects it may be a bad batch. What is the most current patient status? not known. Is the product or representative sample (product from the same lot number) available for evaluation? no. Patient demographics: initials / id; age or date of birth; bmi ; gender- not known. Patient pre-existing medical conditions (ie. Allergies, history of reactions) not known. Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? not know. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported a patient underwent a plastic surgery procedure on an unknown date and topical skin adhesive was used. Post-operatively, the patient suffered a severe skin rash where the product was applied. The rash was treated with steroids. Two weeks later there was still severe inflammation. As a result, the patient lost a nipple. The patient is currently in good condition. There are no samples to return. 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 PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8799083
• MDR Text Key: 151327978
• Report Number: 2210968-2019-84404
• Device Sequence Number: 1
• Product Code: OMD
• 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

• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• 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: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 07/17/2019 Patient Sequence Number: 1