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

Device Problems Material Rupture (1546); Use of Device Problem (1670); Cut In Material (2454)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Type  malfunction  

Event Description

Ref.Imp # (b)(4).

Manufacturer Narrative

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

• Brand Name: SARA 3000
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; komorniki; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3838601
• MDR Text Key: 4412883
• Report Number: 3007420694-2014-00050
• 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: Health Professional,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: 04/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1