MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL UNK LOW SPEED HANDPIECE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hepatitis (1897)

Event Type  Injury  

Event Description

On (b)(6) 2014, dentsply was contacted by an attorney from the u.S.Attorney's office, to obtain sterilization instructions for midwest low speed handpieces.The attorney stated the (b)(6) uses gas to sterilize their low speed handpieces and asked if it was acceptable.Dentsply explained that we have validated steam sterilization and cannot verify if gas sterilization is acceptable.The attorney explained that a patient of the (b)(6) hospital filed a claim alleging that he contracted (b)(6) following a dental treatment where a midwest low speed handpiece and disposable prophy angle where used.The attorney further stated that the (b)(6) does not believe that the patient contracted (b)(6) from the dental treatment, rather, they believe that the patient contracted the virus as a result of his known drug addiction.

Manufacturer Narrative

While it may be possible the patient contracted (b)(6) as a result of his known drug addiction, it is impossible to ascertain as the device was not sterilized according to the directions for use; therefore, because it could be possible that the device contributed to a serious illness in this event, it is reportable per 21 cfr part 803.The device was not returned for evaluation and the serial number was provided for a dhr review.

• Brand Name: UNK LOW SPEED HANDPIECE
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; des plaines IL
• Manufacturer (Section G): DENTSPLY INTL INC; susquehanna commerce center w; 221 w philadelphia st, ste 60; york PA 17401
• Manufacturer Contact: helen lewis ; 901 west oakton st.; des plaines, IL 60018 ; 7178457511
• MDR Report Key: 3964205
• MDR Text Key: 4605531
• Report Number: 1419322-2014-00042
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability