LDX 11-781

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2012-03-29 for LDX 11-781 manufactured by Alere San Diego, Inc..

Event Text Entries

[2576918] Caller alleged that their ldx printer is smoking and gets extremely hot. The printer burned a whole through a label while printing. Customer also reported that the printer does not power off and has to be unplugged to turn off. No report of death or serious injury. Technical services replaced printer.
Patient Sequence No: 1, Text Type: D, B5

[9725623] Investigation pending.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2027969-2012-00429
• MDR Report Key: 2515433
• Report Source: 00,05
• Date Received: 2012-03-29
• Date of Report: 2012-03-29
• Date of Event: 2012-03-02
• Date Mfgr Received: 2012-03-02
• Date Added to Maude: 2012-05-02
• 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: 0
• Event Location: 0
• Manufacturer Contact: CARMEN BERGELIN, MGR.
• Manufacturer Street: 9975 SUMMERS RIDGE RD
• Manufacturer City: SAN DIEGO CA 92121
• Manufacturer Country: US
• Manufacturer Postal: 92121
• Manufacturer Phone: 8588052256
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LDX
• Generic Name: PRINTER, THERMAL, 110V
• Product Code: CHH
• Date Received: 2012-03-29
• Returned To Mfg: 2012-03-12
• Model Number: 11-781
• Lot Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ALERE SAN DIEGO, INC.
• Manufacturer Address: SAN DIEGO CA US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-03-29