MIRROR - DBL SIDED, SZ 5 67723

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-08-12 for MIRROR - DBL SIDED, SZ 5 67723 manufactured by Integra York, Pa Inc..

Event Text Entries

[52720779] On 7/29/16 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - the returned mirror shows scratched reflective surface and detached from frames. While inspecting the mirror it is also noticed that the mirror is detached and have fallen out of frame. Without knowing what temperatures were used when in autoclave and how the mirror was handled during wiping; the cause is undetermined. This type of damage can happen when heat penetrates the reflective surface during autoclaving. The complaint report is confirmed. Device history evaluation - dhr review: nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history: issued for the mirror glass becoming separated from the mirror frame. Issued for double side mirror glass separating form the frame. Health hazard evaluation history: issued for the following reasons: mirror detaching from the frame. Conclusion: the root cause has been identified as a workmanship or material deficiency. Appropriate action has been implemented to rectify this manufacturing deficiency.
Patient Sequence No: 1, Text Type: N, H10


[52720780] Customer initially reports mirrors are coming off of the surface, coming unglued. Fell off in patients mouths. On (b)(6) 2016 customer reports no harm done. This is #3 of 3 related complaints.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523190-2016-00125
MDR Report Key5873647
Report SourceUSER FACILITY
Date Received2016-08-12
Date of Report2016-07-20
Date Mfgr Received2016-07-20
Device Manufacturer Date2014-11-01
Date Added to Maude2016-08-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER SANDRA LEE
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA YORK, PA INC.
Manufacturer Street589 DAVIES DRIVE
Manufacturer CityYORK PA 17402
Manufacturer CountryUS
Manufacturer Postal Code17402
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIRROR - DBL SIDED, SZ 5
Generic NameM52 - HYGIENE / PERIODONTAL
Product CodeEAX
Date Received2016-08-12
Returned To Mfg2016-07-21
Catalog Number67723
Lot NumberM0119
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer Address589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-12

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