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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC.; FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED
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STERILMED, INC.; FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED Back to Search Results
Model Number MIC1333
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Contact with the account concerning the device was made.A response was received indicating that the device(s) will not be returned for a full investigation.Should the complaint device(s) ever be received in the future, an investigation will be conducted and a supplemental report will be sent.The device history report was not reviewed as no lot number was given.
 
Event Description
It was reported that the jaw was bent and the wire was sticking out of the jaw.Broken inside patient.No patient injury or consequence reported.
 
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Type of Device
FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED
Manufacturer (Section D)
STERILMED, INC.
11400 73rd ave n
maple grove MN
Manufacturer Contact
jason anderson
5010 cheshire parkway
suite 2
plymouth, MN 55446
MDR Report Key6520638
MDR Text Key73670420
Report Number2134070-2017-00008
Device Sequence Number1
Product Code NON
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 04/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMIC1333
Device Catalogue NumberMIC1333
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/04/2017
Initial Date FDA Received04/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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