MEDICHOICE 1773088100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-06-15 for MEDICHOICE 1773088100 manufactured by Changzhou Concords Plastic Products Co., Ltd..

Event Text Entries

[1102267] The following was communicated to us by the user facility: the blade on the cord clamp remover dislodged while removing clamp, which became stuck on the clamp while attached to the baby. The blade was loose, but device could not be easily removed from the baby. It took the effort of three rn's to remove the blade and clamp. The baby was not harmed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1451040-2009-00001
• MDR Report Key: 1403435
• Report Source: 99
• Date Received: 2009-06-15
• Date of Report: 2009-06-15
• Date of Event: 2003-03-13
• Date Facility Aware: 2009-04-28
• Report Date: 2009-05-22
• Date Reported to FDA: 2009-05-22
• Date Reported to Mfgr: 2009-05-22
• Date Added to Maude: 2010-03-26
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDICHOICE
• Generic Name: CORD CLAMP REMOVER, UMBILICAL
• Product Code: HFW
• Date Received: 2009-06-15
• Catalog Number: 1773088100
• Lot Number: CCG09-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 2 YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CHANGZHOU CONCORDS PLASTIC PRODUCTS CO., LTD.
• Manufacturer Address: HUADU INDUSTRY ZONE LIJIA TOWN WUJIN, CHANGZHOU 213173 CH 213173

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2009-06-15