STERILE 3.5 SOFT KOH-EFF AD750SC-KE35

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-28 for STERILE 3.5 SOFT KOH-EFF AD750SC-KE35 manufactured by Coopersurgical, Inc..

Event Text Entries

[128747890] Coopersurgical, inc. Is currently investigating the reported complaint condition. Once the investigation is completed a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[128747891] "customer stated on (b)(6) 2018 their was melting of koh soft cup during colpotomy. Per phone call from sale rep (2:10 pm on (b)(4) 2018) the doctor was able to remove all of the melted pieces from the patient. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1216677-2018-00080
MDR Report Key8110334
Date Received2018-11-28
Date of Report2018-11-28
Date of Event2018-10-29
Date Mfgr Received2018-11-12
Device Manufacturer Date2018-09-10
Date Added to Maude2018-11-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PETER NIZIOLEK
Manufacturer Street50 CORPORATE DRIVE
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal06611
Manufacturer Phone2036015200
Manufacturer G1COOPERSURGICAL, INC,
Manufacturer Street75 CORPORATE DRIVE
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal Code06611
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSTERILE 3.5 SOFT KOH-EFF
Generic NameSTERILE 3.5 SOFT KOH-EFF
Product CodeHEW
Date Received2018-11-28
Model NumberAD750SC-KE35
Catalog NumberAD750SC-KE35
Lot Number227-18
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL, INC.
Manufacturer Address95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-11-28

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