CERVICAL DEPTH GAUGE 387.292

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-06-15 for CERVICAL DEPTH GAUGE 387.292 manufactured by Synthes (usa).

Event Text Entries

[19311421] Device report from synthes europe reported an event in (b)(6) as follows: it was reported that a surgical procedure was delayed by 15 minutes due to a problem distinguishing between sleeve part numbers 387. 292 and 03. 161. 028, due to part 387. 292 not having the part number etched on it and the potential for mix-up and mismeasurement since both devices are compatible with several depth gauges. There was no report of patient harm. This complaint is alleged against part number 387. 292. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[19770819] Device was used for treatment, not diagnosis. Patient information was not provided by reporter. (b)(6). Device is an instrument and is not implanted/explanted. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2520274-2015-14478
MDR Report Key4845850
Report Source01,05,07
Date Received2015-06-15
Date of Report2015-05-29
Date of Event2015-05-29
Date Mfgr Received2015-05-29
Date Added to Maude2015-07-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLINDA PLEWS
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCERVICAL DEPTH GAUGE
Generic NameTAPE, MEASURING, RULERS & CALIPERS
Product CodeFTY
Date Received2015-06-15
Catalog Number387.292
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSYNTHES (USA)
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-15

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