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

Model Number	270
Health Effect - Clinical Code	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 dale 270 et tube holder developed a severe facial wound under the dale et holder device.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 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, (b)(4).The dale 270 device packaging for the adhesive base that is applied to the patient's skin contains this wording: apply skin prep.Let dry to prevent skin ulcerations or skin tears, assess patient skin and medical conditions prior to applying.Monitor daily or more frequently.We have found through many years of experience with our 270 device that when all provisions of our instructions for use are followed, including using the supplied skin prep (barrier wipe), there are very few issues reported.Dale medical therefore has concluded that there appears to be no issues with the device and the cause of the facial wound could be related to not using the supplied skin prep (barrier wipe), as the reporting facility had no record of the skin prep being used.
Event or Problem Description
"patient developed severe facial wound under dale et holder device.".

• 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; suite 7; franklin 02038-3298 ; 5083164608
• MDR Report Key: 14013282
• Report Number: 1214422-2022-00005
• Device Sequence Number: 5090253
• 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): 04/04/2022

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
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose