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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #24 GENERAL SURGICAL INSTRUMENTS

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AESCULAP AG CARBON STEEL SCALPEL BLADES #24 GENERAL SURGICAL INSTRUMENTS Back to Search Results
Model Number BB524
Device Problems Nonstandard Device (1420); Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2021
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 bb524 - carbon steel scalpel blades #24. According to the complaint description, the carbon steel scalpel blades are non sterile. There was no described patient harm. Additional information was not provided. Additional patient information is not available. The malfunction is filed under (b)(4).
 
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Brand NameCARBON STEEL SCALPEL BLADES #24
Type of DeviceGENERAL SURGICAL INSTRUMENTS
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 Key12618020
MDR Text Key281165436
Report Number9610612-2021-00688
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB524
Device Catalogue NumberBB524
Device Lot Number4512260156
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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