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

Device Problem Reaction (1514)

Patient Problems Allergic reaction (1701); Blister(s) (1743); Rash (2033); Therapy/non-surgical treatment, additional (2519); Treatment with medication(s) (2571)

Event Date 10/18/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent a cesarean section on (b)(6) 2014 and topical skin adhesive was used.Four days post op, the patient experienced a rash and blisters around the closure site.The patient was seen in the office on (b)(6) 2014.The rash extended approximately 3cm lateral and 3cm superior/inferior of the incision.The adhesive was removed and the patient was prescribed topical steroids.The patient was seen again by the physician on (b)(6) 2014 with significant improvement after steroid treatment.The patient was also seen by a dermatologist on (b)(6) 2014 who confirmed the allergic reaction.

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.

Manufacturer Narrative

The actual device batch number associated with this event is not known.The possible batch number is reported as follows: batch hcp968.In addition, a review of the batch manufacturing records for the possible batch number was conducted and the batches met all finished goods release criteria.

• 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: 4242555
• MDR Text Key: 4993078
• Report Number: 2210968-2014-15554
• 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,Followup
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2014
• 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: 31 YR
• Patient Weight: 81