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

Device Problem Reaction (1514)

Patient Problems Extrusion (1844); Inflammation (1932); Surgical procedure (2357); Impaired Healing (2378); Reaction (2414)

Event Type  Injury  

Event Description

Complaint received via a journal article.It was reported that a patient underwent a soft tissue tumor excision on (b)(6) 2005 and topical skin adhesive was used to close the skin and suture was used on the subcutaneous tissue.Approximately 3 weeks post-operative the wound showed an inflammatory reaction.The patient developed extrusion of the suture, delayed wound healing, and inflammation.After extrusion or excision of the suture material the follow up was uneventful.

Manufacturer Narrative

(b)(6).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.This is one of two medwatches being submitted as two devices were involved in this event.See also medwatch 2210968-2014-10916.The same patient is represented in each medwatch.

• 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: 3994549
• MDR Text Key: 15366235
• Report Number: 2210968-2014-11011
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• 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: 07/16/2014
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR