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

Device Problem Reaction (1514)

Patient Problems Burn(s) (1757); Surgical procedure (2357); Reaction (2414); Treatment with medication(s) (2571)

Event Date 06/20/2014

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient underwent a breast biopsy on (b)(6) 2014 for a bird 4 finding on mammogram and a topical skin adhesive was used.The patient immediately started to experience burning.The wound never closed and she underwent debridement on (b)(6) 2014.She required percocet & dilaudid for the pain.She was diagnosed by a physician with 2nd and 3rd degree burns on (b)(6) 2014.The wound has since healed.She stated that the plastic surgeon has suggested possible scar excision surgery.

Manufacturer Narrative

This medwatch report is associated to maude event report mw 5037261.

Event Description

It was reported by the patient that she underwent a breast biopsy on (b)(6) 2014 and a topical skin adhesive was used to close the incision.She developed ¿burns¿ at the site of application.She underwent wound debridement for 7 days and was treated with silvadene.The wound was negative for bacteria.She is scheduled for a plastic surgery consult for treatment of the open wound.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.

• Brand Name: DERMABOND
• Type of Device: TOPICAL SKIN ADHESIVE
• 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: 3977489
• MDR Text Key: 12222214
• Report Number: 2210968-2014-10737
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2014
• 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
• Patient Age: 43 YR