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

Catalog Number DNX12

Device Problem Reaction (1514)

Patient Problems Itching Sensation (1943); Reaction (2414); Therapy/non-surgical treatment, additional (2519); Treatment with medication(s) (2571)

Event Date 03/04/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent breast implant exchange procedure on an unknown date and topical skin adhesive was used.Two days post-operatively, the patient developed redness, rash and itching at the site.The topical skin adhesive was removed and the patient was administered oral and topical benadryl and steroids.Additional information has been requested.

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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

The actual device batch number associated with this event is not known.The possible batch numbers are reported as follows: batch hlr188; mfg date: 10/20/2014, exp.Date: 09/30/2016.Batch hkr992; mfg.Date: 09/25/2014; exp.Date: 08/31/2016.Batch hkh121; mfg.Date: 09/26/2014; exp.Date: 08/31/2016.Batch hlr382; mfg.Date: 10/21/2014; exp.Date: 09/30/2016.In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.

• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4680730
• MDR Text Key: 5622109
• Report Number: 2210968-2015-04223
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: DNX12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2014
• 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