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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FEHLING INSTRUMENTS GMBH & CO. KG SUPERFLEX SOFT TISSUE RETRACTOR,SPATULA SHAPED, 25X200MM
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FEHLING INSTRUMENTS GMBH & CO. KG SUPERFLEX SOFT TISSUE RETRACTOR,SPATULA SHAPED, 25X200MM Back to Search Results
Model Number MTI-0
Device Problem Device Handling Problem (3265)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2022
Event Type  Injury  
Event Description
It was found intraoperatively that the soft tissue retractor was defective.The patient was not harmed.After the retractor was returned to the manufacturer on december 9, inspection of the retractor revealed that a piece of the retractor had broken out.However, this broken piece was not found in the patient nor outside the patient.
 
Manufacturer Narrative
No patient was harmed.
 
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Brand Name
SUPERFLEX SOFT TISSUE RETRACTOR,SPATULA SHAPED, 25X200MM
Type of Device
SOFT TISSUE RETRACTOR
Manufacturer (Section D)
FEHLING INSTRUMENTS GMBH & CO. KG
hanauer landstr. 7a
karlstein, bavaria 63791
GM  63791
Manufacturer (Section G)
FEHLING INSTRUMENTS GMBH & CO. KG
hanauer landstr. 7a
karlstein, bavaria 63791
GM   63791
Manufacturer Contact
esther bauer
hanauer landstr. 7a
karlstein, bavaria 63791
GM   63791
MDR Report Key16021118
MDR Text Key305874028
Report Number9615005-2022-12001
Device Sequence Number1
Product Code GAD
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician Assistant
Remedial Action Replace
Type of Report Initial
Report Date 12/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMTI-0
Device Catalogue NumberMTI-0
Device Lot Number29140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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