JACOBSON MICRO MOSQ 5 CV 17-2602

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-12-24 for JACOBSON MICRO MOSQ 5 CV 17-2602 manufactured by Integra York, Pa Inc..

Event Text Entries

[5263915] Customer initially reports the tip broke in pt on first use from package. On (b)(6) 2014 customer reports doctor was performing a thyroidectomy when he manipulated the tip of the device under a blood vessel and it broke off. Tip easily retrieved, no harm done. Doctor felt no need for x-ray.
Patient Sequence No: 1, Text Type: D, B5

[12633777] To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2523190-2014-00073
• MDR Report Key: 4380111
• Report Source: 06
• Date Received: 2014-12-24
• Date of Report: 2014-12-04
• Date Mfgr Received: 2014-12-05
• Date Added to Maude: 2015-01-14
• 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: SANDRA LEE
• Manufacturer Street: 315 ENTERPRISE DRIVE
• Manufacturer Phone: 6099366828
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: JACOBSON MICRO MOSQ 5 CV
• Generic Name: M6 - NEURO
• Product Code: EKD
• Date Received: 2014-12-24
• Catalog Number: 17-2602
• Lot Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA YORK, PA INC.
• Manufacturer Address: YORK PA 17402 US 17402

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-12-24