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

Catalog Number DNX12

Device Problem Reaction (1514)

Patient Problems Burn(s) (1757); Itching Sensation (1943); Scar Tissue (2060); Skin Discoloration (2074); Tissue Damage (2104); Burning Sensation (2146); Other (for use when an appropriate patient code cannot be identified) (2200); Therapy/non-surgical treatment, additional (2519); Treatment with medication(s) (2571); No Code Available (3191)

Event Date 06/11/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent a bilateral breast augmentation on an unknown date and topical skin adhesive was used.Two weeks following the procedure at the first postop visit, the patient stated that her skin itched and burned at the site where the skin adhesive was applied on the right side.The physician inspected the wound and no additional care and treatment was ordered at that time.The patient returned on (b)(6) 2015 for another visit.The physician observed skin burns and boils where the adhesive had been applied on the right side.The physician was able to peel the adhesive from the skin but the skin adhered to the product.The patient was given antibiotics prophylactically and a topical wound treatment was also prescribed.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.

Manufacturer Narrative

(b)(4).It was reported that the initial procedure was performed on (b)(6) 2015.The reaction first occurred on (b)(6) 2015.The patient had to re-do the breast augmentation on the right side and is now doing fine.The patient had more tissue damage and scarring on the right side.(b)(4).

Manufacturer Narrative

It was reported that the skin incision site is now pigmented in a darker color corresponding to where the topical skin adhesive was applied.The physician opined that chlorhexidine skin prep was used for this patient.The physician opined that this reaction remains unexplained.(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 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: 4929200
• MDR Text Key: 6051308
• Report Number: 2210968-2015-08808
• 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,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 08/27/2015
• 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