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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional info will be provided upon conclusion of the manufacturer's investigation.

Event Description

(b)(4).

• Brand Name: MINSTREL (INCL. MINERVA)
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; suite 308; san antonio, TX 78247 ; 2102787000
• MDR Report Key: 3659350
• MDR Text Key: 18708045
• Report Number: 3007420694-2014-00009
• 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: User Facility,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: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2004
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1