RUBBER DAM 5X5 GREEN 08561 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-11 for RUBBER DAM 5X5 GREEN 08561 * manufactured by Coltene/whaledent, Inc..

Event Text Entries

[72266] Pt rushed to the hospital 45 minutes after injection. Rubber stem seated, so it's questionable as to what the pt is allergic to. Pt is going to see an allergist.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2411236-1997-01106
• MDR Report Key: 119472
• Date Received: 1997-09-11
• Date of Report: 1997-07-28
• Date of Event: 1997-07-17
• Date Facility Aware: 1997-07-17
• Report Date: 1997-07-28
• Date Added to Maude: 1997-09-16
• Event Key: 0
• Report Source Code: Distributor 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: DENTIST
• 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: RUBBER DAM 5X5 GREEN
• Generic Name: PROTECTIVE BARRIER
• Product Code: EIE
• Date Received: 1997-09-11
• Model Number: 08561
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Expiration Date: 1999-06-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 117131
• Manufacturer: COLTENE/WHALEDENT, INC.
• Manufacturer Address: 750 CORPORATE DR. MAHWAH NJ 07430 US
• Baseline Brand Name: DENTAL DAM
• Baseline Generic Name: ISOLATION/BARRIER PRODUCT
• Baseline Model No: MEDIUM GREEN
• Baseline Catalog No: 101-0171 (SCHEIN)
• Baseline ID: EXP 6/99

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-09-11