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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 3.5MM MINI FULL RAD PLUS 5PK ATHROSCOPIC SHAVER SYSTEM BLADE

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MEDOS INTERNATIONAL SARL 3.5MM MINI FULL RAD PLUS 5PK ATHROSCOPIC SHAVER SYSTEM BLADE Back to Search Results
Model Number 283609
Device Problem Break (1069)
Patient Problems Foreign Body In Patient (2687); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(b)(4). The lot number was unknown. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported by the affiliate in (b)(6) that during a knee arthroscopy procedure on an unknown date, it was observed that the shaver system device had metal abrasions. There were fragments generated that remained inside the patient's knee joint. There was a ten minute delay in the procedure. The procedure was not completed successfully. There were no adverse patient consequences reported. No additional information was provided.
 
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Brand Name3.5MM MINI FULL RAD PLUS 5PK
Type of DeviceATHROSCOPIC SHAVER SYSTEM BLADE
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ CH-2400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ CH-2400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key10838599
MDR Text Key216332162
Report Number1221934-2020-03486
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K131191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283609
Device Catalogue Number283609
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated by Manufacturer? Yes
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: 11/13/2020 Patient Sequence Number: 1
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