AUTO COLLIMATOR 9804-602-82403

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-08-21 for AUTO COLLIMATOR 9804-602-82403 manufactured by Philips Medical Systems.

Event Text Entries

[17415344] Reportedly, the pt was laying on the table during an enema procedure and as the technologist moved the overhead x-ray tube assembly, a cover on the collimator fell off and allegedly struck the pt on the back of the head. The pt reportedly had a small laceration and small bump on her head. She was examined and the cut was cleaned and treated with peroxide.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1217116-1997-00027
• MDR Report Key: 115501
• Report Source: 05,06
• Date Received: 1997-08-21
• Date of Report: 1997-06-24
• Date of Event: 1997-06-24
• Date Facility Aware: 1997-06-24
• Report Date: 1997-06-24
• Date Reported to Mfgr: 1997-07-16
• Date Mfgr Received: 1997-07-16
• Date Added to Maude: 1997-08-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Remedial Action: RP
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AUTO COLLIMATOR
• Generic Name: BEAM LIMITING DEVICE
• Product Code: KPW
• Date Received: 1997-08-21
• Model Number: 9804-602-82403
• Catalog Number: NI
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 113357
• Manufacturer: PHILIPS MEDICAL SYSTEMS
• Manufacturer Address: * BEST NL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-08-21