MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC ASEPTICO MINI HEAD CA - LATCH; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Catalog Number AHP-88MN

Device Problems Detachment of Device or Device Component (2907); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device will not be returned for evaluation.However, the serial number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

In this event it is reported that aseptico mini head ca won't hold files.Outcome of this is unknown as of this mdr.

Manufacturer Narrative

Unsuccessful requests to retrieve suspect product or investigation result have been made and documented.Complaint will be reopened if suspect product or investigation result arrives per 8000-sop-038.- several request have been made to manufacturer/repair center requesting investigation results.As of 1-18-2023 this unit has not been received in their system.No additional information available.

• Brand Name: ASEPTICO MINI HEAD CA - LATCH
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 15624611
• MDR Text Key: 302601451
• Report Number: 2320721-2022-00200
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AHP-88MN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/17/2022
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1