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

Device Problem Reaction (1514)

Patient Problem Reaction (2414)

Event Date 08/31/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent a laparoscopic cholecystectomy on (b)(6) 2014 and topical skin adhesive was used on the four trocar sites.The patient was discharged from the hospital on (b)(6) 2014.The physician received a call on (b)(6) 2014 from the patient.The patient reported that she had developed a rash around the port sites.The patient was seen by the physician on (b)(6) 2014.The patient had a 5-10 cm nonedematous red rash with pruritus around each trocar site.The patient was afebrile.Additional information was 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: 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: 4113052
• MDR Text Key: 18728496
• Report Number: 2210968-2014-13638
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• 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: 09/02/2014
• 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