MAUDE Adverse Event Report: ETHICON INC. DERMABOND

Device Problem Reaction (1514)

Patient Problems Reaction (2414); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported in a medical journal that a patient diagnosed with invasive left breast cancer underwent a mastectomy and a topical skin adhesive was used.Mastectomy flaps were approximated and the adhesive was applied over the length of the wound.Five days postoperatively, an extensive pruritic and erythematous maculopapular rash surrounding the mastectomy incision was observed.The adhesive was immediately removed and the patient was prescribed cetirizine and possible other medications.The patient reported significant symptomatic relief over the next few days with complete resolution of the rash one month later.It was reported on follow-up, that once the rash resolved, the patient had pristine suture lines and that the patient had not undergone an allergy test.

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
• 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: 4524454
• MDR Text Key: 5411507
• Report Number: 2210968-2015-01708
• 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: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• 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: 01/26/2015
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR