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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAPP SURGICAL INSTRUMENT, INC BARIATRIC RING MARKER MARKER RING

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KAPP SURGICAL INSTRUMENT, INC BARIATRIC RING MARKER MARKER RING Back to Search Results
Model Number K9536
Device Problem Break (1069)
Patient Problem Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
On (b)(6) 2017 kapp surgical received an email from (b)(6)with the following text : "subj: bariatric ring marker k9536. What is it made of? mine broke inside of me and they had to remove part of my stomach and intestines die to the damage it caused. Call me please thanks (phone number)" representatives from kapp have attempted to collect aditional information including model number, lot number, and additional details regarding the alleged incident. The last attempt was made (b)(6) 2017. So far (b)(6) has only stated that she was collecting medical records and persuring legal action. No other information has been provided. This report is late because of difficulty setting up the emdr process on our computer system.
 
Event Description
In an email dated (b)(6) 2017 from (b)(6), it was reported "mine broke inside of me and they had to remove part of my stomach and intestines due to the damage it caused. ".
 
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Brand NameBARIATRIC RING MARKER
Type of DeviceMARKER RING
Manufacturer (Section D)
KAPP SURGICAL INSTRUMENT, INC
4919 warrensville center road
cleveland OH 44128
Manufacturer (Section G)
KAPP SURGICAL INSTRUMENT, INC.
4919 warrensville center road
cleveland OH 44128
Manufacturer Contact
nicole merrifield
4919 warrensville center road
cleveland, OH 44128
2165874400
MDR Report Key7130346
MDR Text Key95323941
Report Number1522875-2017-00001
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072216
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 12/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberK9536
Device Catalogue NumberK9536
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/20/2017
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/19/2017 Patient Sequence Number: 1
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