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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #11

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AESCULAP AG CARBON STEEL SCALPEL BLADES #11 Back to Search Results
Model Number BB511
Device Problem Dull, Blunt (2407)
Patient Problem No Information (3190)
Event Date 04/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
Information received by notivisa - an automated system for receipt of adverse events in (b)(6). Limited information, including details of the incident were provided. Information received indicates that the scalpel blades did not cut during use. Five material / lot number combinations were provided. All medwatch reports associated with the report from notivisa include the following: 9610612-2018-00443, 9610612-2018-00444 (this report), 9610612-2018-00445, 9610612-2018-00446, 9610612-2018-00447.
 
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Brand NameCARBON STEEL SCALPEL BLADES #11
Type of DeviceSCALPEL BLADE
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key7916608
MDR Text Key122008698
Report Number9610612-2018-00444
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB511
Device Catalogue NumberBB511
Device Lot Number4508827131
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date09/21/2018
Device Age7 MO
Event Location No Information
Date Manufacturer Received10/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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