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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. SARA 3000 NONE

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ARJOHUNTLEIGH POLSKA SP. ZO.O. SARA 3000 NONE Back to Search Results
Device Problems Bent; Use of Device Problem
Event Type  Injury  
Event Description

Reference importer # (b)(4).

 
Manufacturer Narrative

(b)(4)\. Additional information will be provided following the conclusion of the manufacturer's investigation.

 
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Brand NameSARA 3000
Type of DeviceNONE
Manufacturer (Section D)
ARJOHUNTLEIGH POLSKA SP. ZO.O.
ul. ks. wawrzyniaka 2
komorniki PL-6 2052
PL  PL-62052
Manufacturer (Section G)
ARJOHUNTLEIGH POLSKA SP. ZO.O.
ul. ks. wawrzyniaka 2
komorniki PL-6 2052
PL  PL-62052
Manufacturer Contact
pamela wright
12625 wetmore
ste 308
san antonio , TX 78247
2102787040
MDR Report Key3764657
Report Number3007420694-2014-00045
Device Sequence Number1
Product CodeFNG
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Remedial Action Notification
Type of Report Initial
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/08/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator OTHER
Date Manufacturer Received04/01/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2004
Is The Device Single Use? No
Type of Device Usage Reuse

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