55-100 ML CELL FREEZE CYROGENIC STORAGE CONTAINER CF-500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-06 for 55-100 ML CELL FREEZE CYROGENIC STORAGE CONTAINER CF-500 manufactured by Charter Medical, Ltd..

MAUDE Entry Details

• Report Number: 1066733-2020-00007
• MDR Report Key: 9801924
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2020-03-06
• Date of Report: 2020-03-06
• Date of Event: 2020-02-07
• Date Mfgr Received: 2020-02-07
• Device Manufacturer Date: 2019-11-23
• Date Added to Maude: 2020-03-06
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. LISA HINSHAW
• Manufacturer Street: 3948-A WESTPOINT BLVD.
• Manufacturer City: WINSTON SALEM, NC
• Manufacturer Country: US
• Manufacturer Phone: 7686447422
• Manufacturer G1: CHARTER MEDICAL, LTD.
• Manufacturer Street: 3948-A WESTPOINT BLVD.
• Manufacturer City: WINSTON SALEM, NC
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 55-100 ML CELL FREEZE CYROGENIC STORAGE CONTAINER
• Generic Name: 55-100 ML CELL FREEZE CYROGENIC STORAGE CONTAINER
• Product Code: LPZ
• Date Received: 2020-03-06
• Returned To Mfg: 2020-02-18
• Model Number: CF-500
• Catalog Number: CF-500
• Lot Number: 159167
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CHARTER MEDICAL, LTD.
• Manufacturer Address: 3948-A WESTPOINT BLVD. WINSTON SALEM, NC US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-06