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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC 0.035" HYBRID WIRE, BOX OF 5

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GYRUS ACMI, INC 0.035" HYBRID WIRE, BOX OF 5 Back to Search Results
Model Number GWH3505R
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
The guidewire box (5pk) was returned and is pending evaluation. The cause of the reported event cannot be determined. If additional information becomes available following device evaluation, a supplemental report will be filed.
 
Event Description
The user facility reported that upon receipt the internal packages inside the guidewire box were missing the product label. There was no patient involvement.
 
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Brand Name0.035" HYBRID WIRE, BOX OF 5
Type of Device0.035" HYBRID WIRE, BOX OF 5
Manufacturer (Section D)
GYRUS ACMI, INC
ermsim schwoltbogen 24
dettingen, 72581 72581
GM 72581
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key9419410
MDR Text Key217329242
Report Number2951238-2019-01207
Device Sequence Number1
Product Code EYA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGWH3505R
Device Lot Number91903334
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/18/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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