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

Device Problem Reaction (1514)

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

Event Type  Injury  

Event Description

It was reported that a pediatric patient underwent a wound closure on an unknown date and topical skin adhesive was used.While closing the wound, the patient experienced a severe burning sensation.The physician reported that one layer of the product was applied.The patient may have needed the adhesive removed and had reddened skin at the site.Additional information has been requested.

Manufacturer Narrative

(b)(4).Conclusion code 67: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4).

Manufacturer Narrative

(b)(4).Actual sample was returned for evaluation.The actual sample was disassembled in order to inspect the unit for any anomalies.The device appeared normal in appearance.(b)(4).Representative sample was returned for evaluation.Visual and chemical inspections were performed.The sample performed as designed producing the expected temperature within the expected duration.Residual cleansing agent was likely present at the site when the adhesive was applied which altered the device performance of temperature.

Manufacturer Narrative

The actual device batch number associated with this event is not known.The possible batch number is reported as follows: batch hmr257.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 ADVANCED 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: mary szaro ; 9082183464
• MDR Report Key: 4866389
• MDR Text Key: 6048424
• Report Number: 2210968-2015-07469
• 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,Followup
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: No
• 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