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

Device Problems Defective Component (2292); Dent in Material (2526); Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: SARA 3000
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O; ul ks piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.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: 3888109
• MDR Text Key: 19294671
• Report Number: 3007420694-2014-00061
• Device Sequence Number: 1
• Product Code: FSA
• 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: Inspection
• 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: 04/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1