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

Catalog Number ANX12

Device Problem Reaction (1514)

Patient Problems Unspecified Infection (1930); Reaction (2414); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported that a patient underwent an unknown procedure more than half a year ago and topical skin adhesive was used.The patient developed a severe allergic reaction around a wide area where the topical skin adhesive was used.An anti-allergic agent and a steroid patch were prescribed, however, it took time to calm down the infection.The patient was discharged and recovered.

Manufacturer Narrative

(b)(4).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 ADVANCED TOPICAL SKIN ADHESIVE
• 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: 4913110
• MDR Text Key: 6008927
• Report Number: 2210968-2015-08418
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ANX12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2015
• 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