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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OTTO RUETTGERS GMBH & CO. KG HU-FRIEDY 15C STERILE SCALPEL BLADE, STAINLESS STEEL

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OTTO RUETTGERS GMBH & CO. KG HU-FRIEDY 15C STERILE SCALPEL BLADE, STAINLESS STEEL Back to Search Results
Model Number 40-815C
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/19/2017
Event Type  Injury  
Event Description
It was reported to hu-friedy mfg. Co. , llc that the dentist was performing an implant procedure when the instrument broke in the patient's mouth. The patient swallowed the tip. This follow-up report is to correct initial report # 3009968482-2017-00001. Initially, it was incorrectly reported that the device involved in the event had been returned to the manufacturer. However, while other devices from the same lot were returned to the manufacturer for evaluation, the device involved in the incident was not returned.
 
Event Description
It was reported to (b)(4) that the dentist was performing an implant procedure when the instrument broke in the patient's mouth. The patient swallowed the tip.
 
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Brand NameHU-FRIEDY 15C STERILE SCALPEL BLADE, STAINLESS STEEL
Type of DeviceSTERILE SCALPEL BLADE
Manufacturer (Section D)
OTTO RUETTGERS GMBH & CO. KG
roonstr. 17-19
solingen, nordrhein-westfalen 42699
GM 42699
MDR Report Key6655445
MDR Text Key199236355
Report Number3009968482-2017-00001
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 06/20/2017,07/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Expiration Date08/01/2020
Device Model Number40-815C
Device Catalogue Number40-815C
Device Lot Number3320
Was Device Available for Evaluation? No
Date Returned to Manufacturer05/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA06/20/2017
Distributor Facility Aware Date05/22/2017
Device Age2 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer06/01/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/20/2017 Patient Sequence Number: 1
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