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

Catalog Number CLR222US

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Discoloration (2074)

Event Date 06/26/2018

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.

Event Description

It was reported that a patient underwent a breast augmentation and abdominoplasty procedure on (b)(6) 2018 and topical skin adhesive was used. On (b)(6) 2018 the patient developed a severe allergic reaction on breast and abdomen. The patient was initially treated with medrol dose pack : lotrisone, desonide. The patient was then treated on (b)(6) 2018 with prednisone 20mg with tapering dosage, desonide, and atarax. The patient was seen on (b)(6) 2018 and the reaction was improving. The patient is still on steroids and has large area of hyperpigmentation from the rash / reaction. 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 PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7701481
• MDR Text Key: 114410784
• Report Number: 2210968-2018-74505
• 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
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• 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?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/29/2018
• 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: 07/18/2018 Patient Sequence Number: 1

Treatment

HIBICLENS