MEDI-STIM QUICK FIT PROBE PQ10032 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-29 for MEDI-STIM QUICK FIT PROBE PQ10032 * manufactured by Medistim Usa Inc..

Event Text Entries

[18183025] There are 4 3mm medstim probes and 2 2mm probes that have broken. They are quite fragile and though manufacturer says autoclaveable, they break during the process.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	2412921
MDR Report Key	2412921
Date Received	2011-12-29
Date of Report	2011-10-07
Date of Event	2011-07-25
Report Date	2011-10-07
Date Reported to FDA	2011-12-29
Date Added to Maude	2012-01-12
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
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	0
Event Type	3
Type of Report	3

Device Sequence Number: 1

Brand Name	MEDI-STIM QUICK FIT PROBE
Generic Name	GRAFT PATENCY DEVICE
Product Code	DPW
Date Received	2011-12-29
Returned To Mfg	2011-07-11
Model Number	PQ10032
Catalog Number	*
Lot Number	*
ID Number	*
Device Availability	R
Device Sequence No	1
Device Event Key	0
Manufacturer	MEDISTIM USA INC.
Manufacturer Address	14000 25TH AVE N STE 108 PLYMOUTH MN 55447 US 55447

Device Sequence Number: 2

Brand Name	MEDI-STIM QUICKFIT PROBE
Generic Name	GRAFT PATENCY DEVICE
Product Code	DPW
Date Received	2011-12-29
Returned To Mfg	2011-07-25
Model Number	PQ100022
Catalog Number	*
Lot Number	*
ID Number	*
Device Availability	R
Device Age	1 DY
Device Sequence No	2
Device Event Key	0
Manufacturer	MEDISTIM USA
Manufacturer Address	14000 25TH AVE N STE 108 PLYMOUTH MN 55447 US 55447

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-12-29