HAUSTED ASC 37500 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-09-10 for HAUSTED ASC 37500 * manufactured by Hausted.

Event Text Entries

[20468409] Pt lying in eye chair and positioned for cataract surgery. During procedure the bed fell approx 2 inches. Bed was repositioned and secured. Tear in the capsule resulted from bed movement during surgery. Anterior vitrectomy was necessary and a different lens was needed. Pt may now be at higher risk for retinal detachment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 187416
• MDR Report Key: 187416
• Date Received: 1998-09-10
• Date of Report: 1998-09-03
• Date of Event: 1998-08-24
• Date Facility Aware: 1998-08-24
• Report Date: 1998-09-03
• Date Reported to FDA: 1998-09-04
• Date Reported to Mfgr: 1998-08-24
• Date Added to Maude: 1998-09-17
• 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: HAUSTED
• Generic Name: EYE CHAIR
• Product Code: HMD
• Date Received: 1998-09-10
• Model Number: ASC 37500
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 182168
• Manufacturer: HAUSTED
• Manufacturer Address: 927 LAKE RD P.O. BOX 710 MEDINA OH 442580710 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-09-10