UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-04 for UNKNOWN manufactured by Unknown.

Event Text Entries

[12684] The pt was admitted for excision of a foreign body and chronic abcessed cavity at her previous colostomy incision. The blue plastic foreign body was recognized as a fragment of blue instrument marking tape.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 17050
• MDR Report Key: 17050
• Date Received: 1994-08-04
• Date of Report: 1994-07-29
• Date of Event: 1994-06-21
• Date Facility Aware: 1994-06-21
• Report Date: 1994-07-29
• Date Reported to FDA: 1994-07-29
• Date Added to Maude: 1994-10-24
• 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: UNKNOWN
• Generic Name: COLOR CODING TAPE FOR SURGICAL INST.
• Product Code: MCA
• Date Received: 1994-08-04
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 24 MO
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 16983
• Manufacturer: UNKNOWN
• Manufacturer Address: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	1994-08-04