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

Device Problem Reaction (1514)

Patient Problems Reaction (2414); Therapy/non-surgical treatment, additional (2519)

Event Type  Injury  

Event Description

It was reported that a patient underwent a bilateral breast reduction on an unknown date and a topical skin adhesive was used.On post op day 6, the patient noted an enlarging non-painful but significantly pruritic rash along the incision lines.The topical skin adhesive was removed was removed and within 72 hours the pruritic rash resolved with no additional treatment.

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: 3775977
• MDR Text Key: 21874854
• Report Number: 2210968-2014-05355
• 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,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• 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: 04/07/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR