RUBBER DENTAL DAM UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-02 for RUBBER DENTAL DAM UNK * manufactured by Unk.

Event Text Entries

[128957] Suffered from an anaphalactic reaction following dental work - routine filling. Had rubber dam in mouth, dr and hygenist used latex gloves. Within 20 mins of termination of the procedure, rptr suffered respiratory symptoms, total body hives, rash on neck, intense body itching, and severe distress in all areas of functioning.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1015881
MDR Report Key	213915
Date Received	1999-03-02
Date of Event	1998-04-01
Date Added to Maude	1999-03-16
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
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 Sequence Number: 1

Brand Name	RUBBER DENTAL DAM
Generic Name	*
Product Code	EIE
Date Received	1999-03-02
Model Number	UNK
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	N
Implant Flag	N
Date Removed	A
Device Sequence No	1
Device Event Key	207523
Manufacturer	UNK
Manufacturer Address	UNK UNK *

Device Sequence Number: 2

Brand Name	LATEX GLOVES
Generic Name	*
Product Code	LYY
Date Received	1999-03-02
Model Number	UNK
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	*
Implant Flag	N
Date Removed	A
Device Sequence No	2
Device Event Key	207524
Manufacturer	UNK
Manufacturer Address	UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	1999-03-02