MAUDE Adverse Event Report: DALE MEDICAL PRODUCTS, INC 270 STABILOCK ET HOLDER

Model Number	270
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
"patient has small pressure wound on the inside of her upper left lip and gum area.".
Additional Manufacturer Narrative
It was reported that a patient being treated using the dale 270 et tube holder developed a small pressure wound on the inside of her upper lip and gum area.Dale medical has investigated the report including inspection and testing of a device from the same lot number 27608 as the one reported with no issues noted.A complete review of the device history records for this production lot 27608 also found no issues.Dale medical also performed inspection and testing and dhr review on other production lot's that were produced in the same timeframe with no issues noted.Dale medical has reviewed our customer complaint files and noted that we had no other complaints against the dale 270 device in the last three years; 2019-2021, in that time frame dale has shipped (b)(4) dale 270 devices worldwide.The dale 270 device packaging contains this wording: dale recommends repositioning the endotracheal tube often to help prevent injury to the lips and underlying tissues due to unrelieved pressure.Dale strongly recommends supporting the ventilator tubing to reduce pressure on the face.We have found through many years of experience with our 270 device that when all provisions of our instructions for use are followed there are very few issues reported.Dale medical therefor has concluded that there appears to be no issues with the device and the cause of the pressure sore could be related to the frequency of et tube repositioning.

• Brand Name: 270 STABILOCK ET HOLDER
• Common Device Name: 270 STABILOCK ET HOLDER
• Manufacturer (Section D): DALE MEDICAL PRODUCTS, INC; 40 kenwood circle; suite 7; franklin MA 02038 3298
• Manufacturer (Section G): DALE MEDICAL PRODUCTS, INC.; 40 kenwood circle; suite 7; franklin MA 02038 3298
• Manufacturer Contact: raymond gruneberg ; 40 kenwood circle; sui te 7; franklin, MA 02038-3298 ; 5083164608
• MDR Report Key: 14013193
• Report Number: 1214422-2022-00004
• Device Sequence Number: 12034699
• Product Code: CBH
• UDI-Device Identifier: 00817612020506
• UDI-Public: 00817612020506
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: LISTING ONLY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2025
• Device Model Number: 270
• Device Catalogue Number: 270
• Device Lot Number: 27608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female