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.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: 1.Location and size of the initial scar: back lumbosacral.2.What prep was used prior to, during or after prineo use? not sure.3.Was a dressing placed over the incision? if so, what type of cover dressing used? mepilex border post op.4.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no.5.What is the physicians opinion of the contributing factors to the reaction? contact dermatitis.6.Does the physician believe that the hyperpigmentation around the scar is related to the prineo? yes.7.What is the most current patient status? improved but not disappeared.8.Patient demographics: initials / id; age or date of birth; bmi ; gender: female, 28 years old, chinese.9.Patient pre-existing medical conditions (ie.Allergies, history of reactions).Unknown.10.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? first time.

Manufacturer Narrative

(b)(4).

• 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
• MDR Report Key: 8289598
• MDR Text Key: 134495611
• Report Number: 2210968-2019-78628
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 02/25/2019; 02/25/2019
• Supplement Dates FDA Received: 03/07/2019; 03/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR