APOTHECON *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-11 for APOTHECON * manufactured by Bristol-myers Squibb.

Event Text Entries

[20970] Three packages of nitrazine paper received from wholesaler already reading ph 5. 5-6. 0.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4001509
• MDR Report Key: 39451
• Date Received: 1996-09-11
• Date of Report: 1996-09-10
• Date of Event: 1996-09-10
• 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: 1996-09-11
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 40611
• Manufacturer: BRISTOL-MYERS SQUIBB
• Manufacturer Address: MAIL CODE D2305 PO BOX 4000 PRINCETON NJ 08543 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1996-09-11