V MUELLER DENTAL MIRROR RH4700-008

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-14 for V MUELLER DENTAL MIRROR RH4700-008 manufactured by V Mueller.

Event Text Entries

[16473264] Pt awake - the dr used the dental mirror to assist in spraying the pt's throat for a bronchoscopy. The mirror broke off the shaft, and the pt swallowed it. X-rays were taken and after discussion with the pt, surgical service did an esophageal gastric dilitation and extracted the mirror from the pt's esophagus.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number112628
MDR Report Key112628
Date Received1997-08-14
Date of Report1997-07-14
Date of Event1997-06-24
Date Facility Aware1997-06-24
Report Date1997-07-14
Date Reported to Mfgr1997-07-14
Date Added to Maude1997-08-15
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameV MUELLER DENTAL MIRROR
Generic NameDENTAL MIRROR
Product CodeEAX
Date Received1997-08-14
Model NumberRH4700-008
Catalog NumberRH4700-008
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key110563
ManufacturerV MUELLER
Manufacturer Address1210 WAUKEGAN BLVD MCGAW PARK IL 600856788 US
Baseline Brand NameDENTAL MIRROR
Baseline Generic NameDENTAL MIRROR
Baseline Model NoRH4700-008
Baseline Catalog NoRH4700-008
Baseline IDNA
Baseline Device FamilyDENTAL MIRROR
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1997-08-14

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