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

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(6).

• 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): ARJOHUNTLEIGHT POLSKA SP. ZO.O.; ul ks piotra wawrzyniaka 2; komomiki PL-6 2052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3888097
• MDR Text Key: 4539273
• Report Number: 3007420694-2014-00063
• 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: Repair
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 04/30/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/1999
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1