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

Model Number	270
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Tissue Breakdown (2681)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient being treated using the (b)(4) 270 et tube holder has pressure wound to inside of his upper lip from et tube.There are numerous spots of breakdown inside the front upper lip.(b)(4) 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.(b)(4) 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.(b)(4) medical has reviewed our customer complaint files and noted that we had no other complaints against the (b)(4) 270 device in the last three years; 2019-2021, in that time frame dale has shipped (b)(4) 270 devices worldwide.The (b)(4) 270 device packaging contains this wording: (b)(4) recommends repositioning the endotracheal tube often to help prevent injury to the lips and underlying tissues due to unrelieved pressure.(b)(4) 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.(b)(4) medical therefore has concluded that there appears to be no issues with the device and the cause of the pressure wound and breakdown could be related to the frequency of et tube repositioning.
Event or Problem Description
"patient has pressure wound to the inside of his upper lip from et tube.There are numerous spots of breakdown inside the front upper lip.".

• 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 02038 3298
• Manufacturer (Section G): DALE MEDICAL PRODUCTS, INC.; 40 kenwood circle; suite 7; franklin 02038 3298
• Manufacturer Contact: mr. gruneberg ; 40 kenwood circle; suite 7; franklin 02038-3298 ; 5083164608
• MDR Report Key: 14014670
• Report Number: 1214422-2022-00008
• Device Sequence Number: 2632349
• Product Code: CBH
• UDI-Device Identifier: 00817612020506
• UDI-Public: 00817612020506
• Combination Product (Y/N): N
• 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): 04/05/2022

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
• 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: 07/25/2020
• 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: Male