*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-24 for * manufactured by Unk.

Event Text Entries

[17171762] Anaphylasix to latex dam, and/or latex gloves during a root canal. Rptr felt their tongue swelling and braking out, and becoming painful. Rptr asked the assistant if the rubber dam was made of latex (rptr told her the previous week that she was very allergic to latex, especially when contacted with mucous membranes. Rptr's throat would swell, she would start wheezing, and that she had been like that with each exposure, and the reaction worsened). The aid told the dentist, who in turn put kleenex around her lips between the dam and continued. When he finished, rptr began wheezing and coughing; and eventually stopped breathing. Treated with intravenous epinephrine, benadryl, and steroids.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1014853
• MDR Report Key: 194653
• Date Received: 1998-10-24
• Date of Report: 1998-10-21
• Date of Event: 1998-03-30
• Date Added to Maude: 1998-11-03
• 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: *
• Generic Name: DENTAL RUBBER DAM
• Product Code: EIE
• Date Received: 1998-10-24
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 189113
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Device Sequence Number: 2

• Brand Name: *
• Generic Name: LATEX GLOVES
• Product Code: LYY
• Date Received: 1998-10-24
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 189114
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	1998-10-24