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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
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CHARTER MEDICAL, LTD. 30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER Back to Search Results
Model Number CF-250
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is continuing and an update will follow.
 
Event Description
A bag was found to be leaking from a hole in the film.
 
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Brand Name
30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
Type of Device
30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
Manufacturer (Section D)
CHARTER MEDICAL, LTD.
3948-a westpoint blvd.
winston salem NC 27103 6770
Manufacturer (Section G)
CHARTER MEDICAL, LTD.
3948-a westpoint blvd.
winston salem NC 27103 6770
Manufacturer Contact
charlene grilletto
3948-a westpoint blvd.
winston salem, NC 27103-6770
2675173220
MDR Report Key11318157
MDR Text Key232858656
Report Number1066733-2021-00001
Device Sequence Number1
Product Code LPZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK100049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCF-250
Device Catalogue NumberCF-250
Device Lot Number702095
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age61 YR
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