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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943); Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 02/02/2024

Event Type  Injury  

Event Description

It was reported a patient had an unknown shoulder surgery on an unknown date in 2024 and topical skin adhesive was used.Patient started itching pretty bad, 10/11 inches completely inflamed, red, looks like second degree burns, ended up in the er saturday ((b)(6) 2024), went into mouth and back of my throat, sores on my lips.On an oral steroid, and topical steroid extremely red, has blisters, has worked its way down to my arm, and onto my peck muscle area, blistering at the incision, puffy underneath.Looks like second degree burns.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Is a photo available of the patient reaction? name of surgery? what was the procedure date? what date /day post op was the reaction noted? if in your possession, may we have a copy of your operative report? requested your permission to contact your surgeon.No product available for return.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DERMABOND UNKNOWN PRODUCT
• Type of Device: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18790593
• MDR Text Key: 336399913
• Report Number: 2210968-2024-01982
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2024
• 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