MAUDE Adverse Event Report: ETHICON INC. DERMABOND

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Reaction (2414); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 in a journal article that a patient underwent bilateral patellar maltracking procedure on right knee on an unknown date and topical skin adhesive was used.The patient was closed with subcutaneous sutures and then covered by topical skin adhesive.Following the procedure the patient experienced delayed type hypersensitivity reaction.On postoperative day eight, the patient presented with pain, erythema, and swelling around the incision site.The patient also developed a small dehiscence of the inferior aspect of the surgical incision.The patient returned to the operating room two weeks later for a successful irrigation and debridement and revision wound closure.Intraoperative cultures were taken and were negative for organisms.Patient went on to successful wound healing at four weeks after return to operating room.

• Brand Name: DERMABOND
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6358289
• MDR Text Key: 68348130
• Report Number: 2210968-2017-30863
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2017

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 02/24/2017
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 2-0 VICRYL, 4-0 MONOCRYL SUTURE
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR