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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG TC METZENBAUM SCISSORS DEL CVD 200MM; DUROTIP SCISSORS
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AESCULAP AG TC METZENBAUM SCISSORS DEL CVD 200MM; DUROTIP SCISSORS Back to Search Results
Model Number BC275R
Device Problems Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).When additional information is received a follow up report will be submitted.
 
Event Description
It was reported by the healthcare professional "that the wrong item number is on the scissors." the product is mislabeled.All med watch submissions related to this are: 9610612-2019-00203; 9610612-2019-00204.
 
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Brand Name
TC METZENBAUM SCISSORS DEL CVD 200MM
Type of Device
DUROTIP SCISSORS
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
MDR Report Key8464013
MDR Text Key140310704
Report Number9610612-2019-00205
Device Sequence Number1
Product Code LRW
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 foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBC275R
Device Catalogue NumberBC275R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2019
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date03/21/2019
Date Manufacturer Received03/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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