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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. MINSTREL (INCL. MINERVA) NONE

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ARJOHUNTLEIGH POLSKA SP. ZO.O. MINSTREL (INCL. MINERVA) NONE Back to Search Results
Device Problem Device Tipped Over
Event Type  Malfunction  
Event Description

(b)(4).

 
Manufacturer Narrative

This report is being filed under exemption (b)(4) by arjohuntleigh (b)(4) (registration# (b)(4)) on behalf of the importer arjohuntleigh, inc. ((b)(4)) (registration#(b)(4)).

 
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Brand NameMINSTREL (INCL. MINERVA)
Type of DeviceNONE
Manufacturer (Section D)
ARJOHUNTLEIGH POLSKA SP. ZO.O.
ul ks piotra wawrzyniaka 2
komorniki PL-6 2052
PL  PL-62052
Manufacturer (Section G)
ARJOHUNTLEIGH POLSKA SP. ZO.O.
ul ks piotra wawrzyniaka 2
komomiki 6205 2
PL  62052
Manufacturer Contact
pamela wright
12625 wetmore
ste 308
san antonio , TX 78247
2102787040
MDR Report Key3888098
Report Number3007420694-2014-00062
Device Sequence Number1
Product CodeFNG
Report Source Manufacturer
Source Type 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 Received05/30/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator OTHER
Date Manufacturer Received04/26/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2013
Is The Device Single Use? No
Type of Device Usage Unkown

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