MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. KINAIRMEDSURG

Device Problems Bent (1059); Crack (1135)

Patient Problem Fall (1848)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the mfg site kinetics concept inc.From november 2012 until 2014 complaints related to these products were handled by arjohuntleigh inc.Additional info will be provided upon conclusion of the investigation.

• Brand Name: KINAIRMEDSURG
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH 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: 4536806
• MDR Text Key: 5538224
• Report Number: 3009988881-2015-00008
• Device Sequence Number: 1
• Product Code: INX
• 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: 01/23/2015
• Initial Date FDA Received: 02/12/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1