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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #22

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AESCULAP AG CARBON STEEL SCALPEL BLADES #22 Back to Search Results
Model Number BB522
Device Problem Dull, Blunt (2407)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2021
Event Type  malfunction  
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 bb522 - carbon steel scalpel blades #22. According to the complaint description, the blade of the scalpel is blunt. There was no described patient harm. Additional information was not provided. Additional information has been requested but not yet received as of this report. Additional patient information is not available. The malfunction is filed under aag reference (b)(4).
 
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Brand NameCARBON STEEL SCALPEL BLADES #22
Type of DeviceSCALPEL BLADES
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 Key11731836
MDR Text Key253237070
Report Number9610612-2021-00338
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
EXEMPT
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 10/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB522
Device Catalogue NumberBB522
Device Lot Number4511883671
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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