UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-16 for UNK * manufactured by Unk.

Event Text Entries

[88363] Had dental procedure; root canal. Reported, prior to procedure, a problem with gloves, causing hives, itching, running nose & itchy eyes. Dental student used dental dam & gloves. At end of procedure, 1/2 of rptrs face was swollen, red & had hives. Rptr was given p. O. Benadryl. Tremors started every 30-45 seconds. Monitored rptr's heart, bp & pulse ox. X 1 hr and gave rptr benadryl 50mgm 1 hr. Rptr left clinic in wheelchair to car. Took 50mgm benadryl p. O. H. S. Then saw allergist. Rptr's bp initially was elevated during episode. Since rptr has been diagnosed w/severe latex allergy. 2 visits to allergist. Now on zyrtec qd, carry epi-pen & benadryl and premedicate w/prednisone & benadryl for procedures.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1012732
• MDR Report Key: 141391
• Date Received: 1997-12-16
• Date of Report: 1997-12-15
• Date of Event: 1997-10-14
• Date Added to Maude: 1998-01-06
• 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: UNK
• Generic Name: LATEX GLOVES
• Product Code: LYY
• Date Received: 1997-12-16
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 137977
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Device Sequence Number: 2

• Brand Name: UNK
• Generic Name: DENTAL DAM, ETC
• Product Code: EIE
• Date Received: 1997-12-16
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 137978
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	1997-12-16