BUSSE HOSPITAL DISPOSABLES 3MM 206

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 2003-02-12 for BUSSE HOSPITAL DISPOSABLES 3MM 206 manufactured by Busse Hospital Disposables.

Event Text Entries

[287308] The pt experienced anaphylactic shock within 30 minutes of the insertion of the laminaria. The pt was given an injection of benadryl and the laminaria was removed. The pt responded favorably.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2433012-2003-00001
• MDR Report Key: 442980
• Report Source: 05,06
• Date Received: 2003-02-12
• Date of Report: 2003-02-11
• Date of Event: 2003-01-23
• Date Mfgr Received: 2003-01-24
• Date Added to Maude: 2003-02-20
• 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: 0
• Manufacturer Contact: VICKI ATOR
• Manufacturer Street: 75 ARKAY DR
• Manufacturer City: HAUPPAUGE NY 11788
• Manufacturer Country: US
• Manufacturer Postal: 11788
• Manufacturer Phone: 6314354711
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BUSSE HOSPITAL DISPOSABLES
• Generic Name: LAMINARIA CERVICAL DIALATOR
• Product Code: HDY
• Date Received: 2003-02-12
• Model Number: 3MM
• Catalog Number: 206
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 431953
• Manufacturer: BUSSE HOSPITAL DISPOSABLES
• Manufacturer Address: 75 ARKAY DR HAUPPAUGE NY 11788 US
• Baseline Brand Name: BUSSE HOSPITAL DISPOSABLES
• Baseline Generic Name: LAMINARIA CERVICAL DIALATOR
• Baseline Model No: 3MM
• Baseline Catalog No: 206
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2003-02-12