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

Catalog Number DHVM12

Device Problem Reaction (1514)

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

Event Type  Injury  

Event Description

It was reported that a patient underwent a laparoscopic nissen fundoplication procedure on (b)(6) 2014 and topical skin adhesive was used.Three days post-operatively, the patient developed a severe skin reaction.There was a red, raised area around each of the 5 port sites that progressed to the abdomen.The patient was given a medrol dose pack.The reaction has cleared up, but the patient has occasional flare ups.

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 TOPICAL SKIN ADHESIVE
• Type of Device: ADHESIVE, TOPICAL SKIN
• 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: 3782145
• MDR Text Key: 4378940
• Report Number: 2210968-2014-05481
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DHVM12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2014
• 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: 57 YR
• Patient Weight: 88