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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #15 BASIC INSTRUMENTS

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AESCULAP AG CARBON STEEL SCALPEL BLADES #15 BASIC INSTRUMENTS Back to Search Results
Model Number BB515
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 03/26/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 the scalpel blade. While attempting to insert a blade onto the handle, the assistant cut herself deeply in her thumb. The blade was noted to have "jumped" out of the packaging. It was reported that the assistant was doing well and in the healing process. Further information has been requested.
 
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Brand NameCARBON STEEL SCALPEL BLADES #15
Type of DeviceBASIC 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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8511625
MDR Text Key141894821
Report Number9610612-2019-00269
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 04/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBB515
Device Catalogue NumberBB515
Device Lot Number4509129959
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/10/2019
Device Age14 MO
Event Location No Information
Date Manufacturer Received04/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/12/2019 Patient Sequence Number: 1
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