MAUDE Adverse Event Report: ETHICON INC. DERMABOND; ADHESIVE, TOPICAL, SKIN

Device Problem Reaction (1514)

Patient Problems Blister(s) (1743); Lesion (1950); Reaction (2414); Treatment with medication(s) (2571)

Event Date 06/14/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent a spinal fusion on (b)(6) 2015 and topical skin adhesive was used.An ioban was placed over the incision and removed two to three days post-op.A reaction was noted at that time.The blisters worsened and again at 6 days post-op.Upon inspection, there were vesicular lesions underneath the skin adhesive and were tracking distally.The patient was treated with oral benadryl, and triamcinolone cream to distal blisters.The surgeon is considering benadryl cream over the skin adhesive and there are plans to remove the adhesive.The patient is still in-patient, which was part of the expected course of care post-op.Additional information has been requested.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.(b)(4).

• Brand Name: DERMABOND
• Type of Device: ADHESIVE, TOPICAL, SKIN
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 0075 4
• Manufacturer Contact: mary szaro ; 9082183464
• MDR Report Key: 4909380
• MDR Text Key: 6538159
• Report Number: 2210968-2015-08303
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• 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
• Date Manufacturer Received: 06/17/2015
• 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
• Patient Outcome(s): Required Intervention