MERCURY MEDICAL INFANT 10-55203

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-10-06 for MERCURY MEDICAL INFANT 10-55203 manufactured by Mercury Medical.

Event Text Entries

[15560837] Oxygen reservoir bag off the pt cpr bag was not sealed all the way.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1024404-2004-00005
• MDR Report Key: 677833
• Report Source: 05,06
• Date Received: 2004-10-06
• Date of Report: 2004-06-30
• Date Mfgr Received: 2003-11-20
• Device Manufacturer Date: 2003-07-01
• Date Added to Maude: 2006-02-23
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: MR AL SOUSA
• Manufacturer Street: 11300 49TH ST N
• Manufacturer City: CLEARWATER FL 33762
• Manufacturer Country: US
• Manufacturer Postal: 33762
• Manufacturer Phone: 7275730088
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: IN
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MERCURY MEDICAL
• Generic Name: CPR BAG
• Product Code: LYM
• Date Received: 2004-10-06
• Model Number: INFANT
• Catalog Number: 10-55203
• Lot Number: 3160203
• ID Number: NA
• Device Availability: R
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 667103
• Manufacturer: MERCURY MEDICAL
• Manufacturer Address: * CLEARWATER FL * US
• Baseline Brand Name: MERCURY MEDICAL
• Baseline Generic Name: CPR BAG
• Baseline Model No: INFANT
• Baseline Catalog No: 10-55203
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-10-06