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

Catalog Number DERMAADVUNK

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

Patient Problem Necrosis (1971)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: five sutures.Used honey, did not work.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Please verify the event information above for accuracy.How are you feeling? do you know the dermabond product code used during your procedure? if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event we would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? no product return available.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.

Event Description

It was reported a patient fell getting into the shower on (b)(6) 2023 and topical skin adhesive was used.Fell with all weight came down on the medal railing, crush laceration/wound.The er for sutured, deep enough that you could see the muscle and tendon.Er doctor, small sutures out in 10 days, tells me, one little area on the end, just glued it.The deepest most open parts just covered with glue, as soon as the air hit it turned black, quarter of an inch deeper, needs debridement.Now at a wound clinic, adhesive with necrotic tissue underneath.Additional information has been requested.

• Brand Name: DERMABOND ADVANCED 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 PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18050919
• MDR Text Key: 327127951
• Report Number: 2210968-2023-08445
• 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: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DERMAADVUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2023
• 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