ZIMMER SE02 87 200 120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-03-28 for ZIMMER SE02 87 200 120 manufactured by Leonhard Lang Gmbh.

Event Text Entries

[70989789] The customer did not return the entire involved device but sent us only the metal wire he had recovered from its surface. The piece of wire is about 40mm of length and has a diameter of 0,39mm. The investigation revealed that the wire must have been introduced inadvertently onto the gel surface in the production machine. The only conceivable source is a steel brush used at a nearby packaging machine, although the diameter of its strands appears to differ in diameter. Corrective action to prevent recurrence is being developed and will be implemented.
Patient Sequence No: 1, Text Type: N, H10


[70989790] On (b)(6) 2017, we have been informed about an incident with zimmer stimulation electrodes. During a therapy session a patient received stimulation through a pair of stimulation electrodes. During the treatment, the patient started to feel pain. The therapist responded immediately, checked the electrodes and discovered an approximately 40 mm long metal strand. No medical intervention was necessary. Nor further details on the patient and the procedure have been disclosed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020045-2017-00011
MDR Report Key6438621
Report SourceDISTRIBUTOR,FOREIGN
Date Received2017-03-28
Date of Report2017-03-28
Date Mfgr Received2017-03-01
Device Manufacturer Date2017-01-30
Date Added to Maude2017-03-28
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 ContactMR. BURRHUS LANG
Manufacturer StreetARCHENWEG 56 6020 INNSBRUCK
Manufacturer CityINNSBRUCK, TIROL
Manufacturer CountryAU
Manufacturer Phone512 334254
Manufacturer G1LEONHARD LANG GMBH
Manufacturer StreetARCHENWEG 56
Manufacturer CityINNSBRUCK, TIROL 6020
Manufacturer CountryAU
Manufacturer Postal Code6020
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZIMMER
Generic NameSTIMULATION ELECTRODE
Product CodeGXY
Date Received2017-03-28
Returned To Mfg2017-03-13
Model NumberSE02
Catalog Number87 200 120
Lot Number70130-0641
Device Expiration Date2019-01-31
OperatorOCCUPATIONAL THERAPIST
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLEONHARD LANG GMBH
Manufacturer AddressARCHENWEG 56 INNSBRUCK, TIROL 6020 AU 6020


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-03-28

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