APOTHECON *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-24 for APOTHECON * manufactured by Bristol-myers Squibb.

Event Text Entries

[26229] Nitrazine paper dispenser was picked up to use. Entire contents were light green (ph approx 5. 5). Tape usually comes bright yellow from mfr. Not aware of any exposure to alkali or acid fumes. Product returned to pharmacy not used.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4001508
• MDR Report Key: 39449
• Date Received: 1996-09-24
• Date of Report: 1996-08-29
• Date of Event: 1996-08-29
• Date Added to Maude: 1996-09-26
• 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: PHARMACIST
• 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: APOTHECON
• Generic Name: NITRAZINE PAPER
• Product Code: LNW
• Date Received: 1996-09-24
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 40609
• Manufacturer: BRISTOL-MYERS SQUIBB
• Manufacturer Address: MAIL CODE D2305 PO BOX 4000 PRINCETON NJ 08543 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1996-09-24