MIRA INC *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-17 for MIRA INC * manufactured by Mira.

Event Text Entries

[161302] Pt had a routine vitrectomy for vitreous hemorrhage. After the blood was removed it was apparent that the service of his hemorrhage was a retinal tear in the right eye. The cryo probe machine would not function and could not permit an adequate freeze. Four probes use (tested). All failed to work. As a result the pt's retina detached. Pt. Had placement of a scleral buckle and an intraocular gas bubble. Pt returned 12/18/99 for revision mechanical pais plana vitrectomy. Right pais plana lensectomy right eye. Lysis of posterior synechia, od, pysil stretching with iris reltactoes od. Posterior chamber 10l implantation right eye. Orcunid choroedal effusions, laser indirect opthalmoscope fariretinal & surgical posterior capsulotomy.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 259623
• MDR Report Key: 259623
• Date Received: 2000-01-17
• Date of Report: 2000-01-17
• Date of Event: 1999-12-02
• Date Facility Aware: 1999-12-31
• Report Date: 2000-01-17
• Date Reported to FDA: 2000-01-17
• Date Reported to Mfgr: 2000-01-17
• Date Added to Maude: 2000-01-27
• 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 Details

• Brand Name: MIRA INC
• Generic Name: CRYOPROBE
• Product Code: HPS
• Date Received: 2000-01-17
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 251423
• Manufacturer: MIRA
• Manufacturer Address: 87 RUMFORD WALTHAM MA 02154 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2000-01-17