MAUDE Adverse Event Report: ETHICON INC. DERMABOND HV 0.5ML VIAL - 12EA; ADHESIVE, TOPICAL SKIN

Catalog Number AHV12

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2023

Event Type  malfunction  

Event Description

It was reported a patient underwent a mastopexy on (b)(6) 2023 and topical skin adhesive was used.The glue came with defects, the surgical center did not accept it procedure was completed without the glue.Upon receipt and analysis inside an opened package.The visual analysis of the device revealed that the tip of the pen was broken.

Manufacturer Narrative

Product complaint # (b)(4).Additional information provided: the product was stored according to the manufacturer's instructions.If further details are received at a later date a supplemental medwatch will be sent.Evaluation: visual inspection was conducted on the returned device.The analysis results found that a device was returned inside its opened package.The visual analysis of the device revealed that the tip of the pen was broken.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the reported incident.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 HV 0.5ML VIAL - 12EA
• 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: 16726160
• MDR Text Key: 313167533
• Report Number: 2210968-2023-02654
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AHV12
• Device Lot Number: SHBHES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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