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

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Rash (2033); Skin Discoloration (2074); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.Additional information was requested and the following was obtained: please describe how the adhesive was applied on the tape - the incision was wiped down with water, and dried.Stratafix suture was used to close the subq.The surgeon typically uses 2 prineo with knee flexed.What prep was used prior to product application? unknown , but there has been no changes what date did the reaction occur on? 10-14 days.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify ¿ some patients were referred to dermatology.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.

Event Description

It was reported that a female patient underwent a hip surgery on (b)(6) 2018 and topical skin adhesive was used.On (b)(6) 2018 the patient presented with dermatitis and a rash.The patient was put on keflex.On (b)(6) 2018 the patient called complaining of remaining rash remnants.Additional information was 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 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7293308
• MDR Text Key: 100832343
• Report Number: 2210968-2018-71024
• 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: Other
• Type of Report: Initial
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR