OLYMPUS 100 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-15 for OLYMPUS 100 * manufactured by Olympus.

Event Text Entries

[203615] Rptr went to clinic for annual physical. Flexible sigmoidoscopy was done. Rptr was examined and experienced a great amount of pain. When in bathroom later there was bleeding. Ice applied but pain worsened. Returned to clinic and dr diagnosed lacerations. Given a cream and told to sit in hot water. Eight to ten months later rptr went to a dr not from the clinic who diagnosed ulcerations.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1021095
• MDR Report Key: 316237
• Date Received: 2001-02-15
• Date of Report: 2001-02-15
• Date of Event: 1996-10-11
• Date Added to Maude: 2001-02-20
• 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
• 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: OLYMPUS
• Generic Name: FLEXIBLE SIGMOIDSCOPE
• Product Code: FAM
• Date Received: 2001-02-15
• Model Number: 100
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 305799
• Manufacturer: OLYMPUS
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-02-15