30 - 70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CF-250

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-24 for 30 - 70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CF-250 manufactured by Charter Medical, Ltd..

MAUDE Entry Details

• Report Number: 1066733-2019-00004
• MDR Report Key: 8824153
• Date Received: 2019-07-24
• Date of Report: 2019-07-24
• Date of Event: 2019-06-25
• Date Mfgr Received: 2019-06-25
• Device Manufacturer Date: 2019-04-18
• Date Added to Maude: 2019-07-24
• 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: MR. TODD MEINECKE
• Manufacturer Street: 3948-A WESTPOINT BLVD.
• Manufacturer City: WINSTON SALEM NC 27103
• Manufacturer Country: US
• Manufacturer Postal: 27103
• Manufacturer Phone: 3367686447
• Manufacturer G1: CHARTER MEDICAL, LTD.
• Manufacturer Street: 3948-A WESTPOINT BLVD.
• Manufacturer City: WINSTON SALEM NC 27103
• Manufacturer Country: US
• Manufacturer Postal Code: 27103
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: 30 - 70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Generic Name: 30 - 70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Product Code: LPZ
• Date Received: 2019-07-24
• Returned To Mfg: 2019-07-23
• Model Number: CF-250
• Catalog Number: CF-250
• Lot Number: 152678
• 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 27103 US 27103

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-07-24