MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC SPIRIT SELECT

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Imp ref #(b)(4).

Manufacturer Narrative

Please note that this product is not longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc (under registration#1625774).From november 2012 medwatch reports related to complaints to this product will be submitted under registration #3009988881.Additional information will be provided upon conclusion of the investigation.

• Brand Name: SPIRIT SELECT
• Manufacturer (Section D): ARJOHUNTLEIGH, INC; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLGITH, INC; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore rd ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4420425
• MDR Text Key: 17266745
• Report Number: 3009988881-2015-00004
• Device Sequence Number: 1
• Product Code: IKZ
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 01/12/2015
• 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