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

Catalog Number AHV12

Device Problem Reaction (1514)

Patient Problems Allergic reaction (1701); Therapy/non-surgical treatment, additional (2519)

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient underwent an unknown procedure on unknown date and the topical skin adhesive was used.After applying a topical skin adhesive, the patient experienced an allergic contact dermatitis.The patch test with topical skin adhesive was positive.Additional information has been requested.

Event Description

It was reported by the sales rep that, after applying dermabond, allergic contact dermatitis occurred on the ambulatory patient.Patch test with dermabond was positive.The details and lot number are not provided from the hp.No sample will be returned.The patient¿s information, such as id, initials, age, body weight, previous medical conditions and medications were not provided from the hp.Affiliate reference number is (b)(4).

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.Additional information: the actual device batch number associated with this event is not known.One possible batch number is reported as follows:.

Manufacturer Narrative

Date sent to the fda: 09/04/2015.Additional narrative: the procedure was a colostomy and the topical skin adhesive was used on the dermis.Steroid medication was prescribed to treat the reaction.Due to steroid medication, the patient recovered.Additional information: the actual device batch number associated with this event is not known.One possible batch number is reported as follows: batch # (b)(4), mfg date 07/24/2008, exp date 06/30/2010.(b)(4).

• Brand Name: DERMABOND TOPICAL SKIN ADHESIVE
• Type of Device: ADHESIVE, TOPICAL SKIN
• 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: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4960844
• MDR Text Key: 14234383
• Report Number: 2210968-2015-10644
• 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: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AHV12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: No
• 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