SKLAR 91-5190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-28 for SKLAR 91-5190 manufactured by Sklar Instruments.

Event Text Entries

[58845339] During a leep procedure, the pt was somehow burned. Instruments involved included: sklar lateral retractor #(b)(4), euro-med vaginal speculum #(b)(4), euro-med tenaculum #(b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW5065681
MDR Report Key6066335
Date Received2016-10-28
Date of Report2016-10-17
Date of Event2016-06-06
Date Added to Maude2016-10-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameSKLAR
Generic NameLATERAL RETRACTOR
Product CodeEIG
Date Received2016-10-28
Returned To Mfg2016-08-08
Model Number91-5190
Catalog Number91-5190
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSKLAR INSTRUMENTS
Manufacturer AddressWEST CHESTER PA US

Device Sequence Number: 2

Brand NameEURO-MED VAGINAL SPECULUM
Generic NameVAGINAL SPECULUM
Product CodeHIB
Date Received2016-10-28
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No2
Device Event Key0
ManufacturerCOOPERSURGICAL, INC.

Device Sequence Number: 3

Brand NameEURO-MED TENACULUM
Generic NameTENACULUM
Product CodeHGC
Date Received2016-10-28
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No3
Device Event Key0
ManufacturerCOOPERSURGICAL, INC.

Patients

Patient NumberTreatmentOutcomeDate
10 2016-10-28
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