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

Device Problem Device Tipped Over (2589)

Patient Problem No Information (3190)

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)).

• Brand Name: MINSTREL (INCL. MINERVA)
• Type of Device: NONE
• 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 Key: 3888098
• MDR Text Key: 4424872
• Report Number: 3007420694-2014-00062
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Remedial Action: Notification
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 04/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1