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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE ANGLED HDPC 1:2 F/2.35X70MM HIGHSPEED POWER SYSTEMS

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AESCULAP AG MICRO-LINE ANGLED HDPC 1:2 F/2.35X70MM HIGHSPEED POWER SYSTEMS Back to Search Results
Model Number GD455M
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 11/25/2020
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with gd455m - micro-line angled hdpc 1:2 f/2. 35x70mm. According to the complaint description, the handpiece has begun to heat up during use which caused a 2nd degree burn to the patient. This occurred during excision of a super-infected impacted wisdom tooth. An additional medical intervention was necessary. Additional information was not provided nor available / was not available. The adverse event / malfunction is filed under aag reference (b)(4).
 
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Brand NameMICRO-LINE ANGLED HDPC 1:2 F/2.35X70MM
Type of DeviceHIGHSPEED POWER SYSTEMS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key11021157
MDR Text Key222053079
Report Number9610612-2020-00916
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
A883357
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGD455M
Device Catalogue NumberGD455M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/16/2020 Patient Sequence Number: 1
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