SIGMA I.V. POLE UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-22 for SIGMA I.V. POLE UNK manufactured by Pryor Products.

Event Text Entries

[15448453] As the pt was being brought back from the x-ray dept, the wheels of the intravenous pole got caught on the threshold of the elevator. The pole tipped over and struck the pt on the right eye area, resulting in bleeding around and from the right eye. The pt complained of pain and loss of vision. He rec'd initial treatment from an ophthalmologist at this facility, but due to the seriousness of the injury he was transferred to a tertiary care center to a retina-vitreous specialist for surgical evaluation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 204223
• MDR Report Key: 204223
• Date Received: 1998-12-22
• Date of Report: 1998-10-19
• Date of Event: 1998-10-09
• Date Facility Aware: 1998-10-09
• Report Date: 1998-10-19
• Date Reported to Mfgr: 1998-10-19
• Date Added to Maude: 1999-01-04
• 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
• 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: SIGMA I.V. POLE
• Generic Name: I.V. POLE
• Product Code: FOA
• Date Received: 1998-12-22
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: 46260-1979
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 198356
• Manufacturer: PRYOR PRODUCTS
• Manufacturer Address: 1819 PEACOCK BLVD. OCEANSIDE CA 92056 US
• Baseline Brand Name: SIGMA I.V. POLE
• Baseline Generic Name: I.V. POLE
• Baseline Model No: UNK
• Baseline Catalog No: UNK
• Baseline ID: 46260-1979

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-12-22