ULTRASOUND *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-15 for ULTRASOUND * manufactured by Unk.

Event Text Entries

[51406] On sept. 2. 1993 an ultrasound was routinely performed on pt. Who was 20 wks pregnant. During the ultrasound the tech zoomed in on the eye. The baby later went blind in one eye due to rupture of a small blood vessell in the eye. The time of the rupture of the small blood vessell was set at about midway during the pregnancy.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1011318
• MDR Report Key: 91237
• Date Received: 1997-05-15
• Date of Report: 1997-05-09
• Date of Event: 1993-09-02
• Date Added to Maude: 1997-05-19
• Event Key: 0
• Report Source Code: Voluntary 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: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ULTRASOUND
• Generic Name: FETAL ULTRASOUND
• Product Code: LXE
• Date Received: 1997-05-15
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 90138
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	1997-05-15