STEAM STER LOCKS ORANGE US906

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-07-26 for STEAM STER LOCKS ORANGE US906 manufactured by Aesculap Ag.

Event Text Entries

[50512899] Manufacturing site investigation is on-going. Contract manufacturer: (b)(4). Pma 510(k): k890764.
Patient Sequence No: 1, Text Type: N, H10


[50512900] Country of complaint: usa. Customer reported that following processing of steril containers it was observed that the orange locks dots are changing back to blue. The customer stated that this caused a delay in several surgeries because they had to reprocess sets again.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916714-2016-00642
MDR Report Key5824082
Report SourceCOMPANY REPRESENTATIVE
Date Received2016-07-26
Date of Report2016-07-26
Date of Event2016-06-20
Date Facility Aware2016-06-21
Date Mfgr Received2016-06-27
Date Added to Maude2016-07-26
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 FDA3
Event Location3
Manufacturer ContactMS. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145515988
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTEAM STER LOCKS ORANGE
Generic NamePROCESS INDICATOR LOCK
Product CodeKCT
Date Received2016-07-26
Model NumberUS906
Catalog NumberUS906
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-07-26

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