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

Device Problem Reaction (1514)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

It was reported that the patient underwent total knee replacement on an unknown date and topical skin adhesive was used.Following the procedure, the patient had a reaction to the topical skin adhesive.It is unknown if topical skin adhesive was removed.Additional information has been requested.

Manufacturer Narrative

(b)(4).Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4393779
• MDR Text Key: 5302774
• Report Number: 2210968-2015-00131
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• 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: 12/19/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention