MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB TRINOVA

Device Problem Burst Container or Vessel (1074)

Patient Problems Bruise/Contusion (1754); Skin Tears (2516)

Event Type  malfunction  

Event Description

Ref # imp (b)(4).

Manufacturer Narrative

This report is being filed by arjohuntleigh, inc and is submitted on behalf of the manufacturer (arjo (b)(4).Manufacturers complaint reference no: (b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.Additional serial # (b)(4), mattress.

• Brand Name: TRINOVA
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall; houghton regis, bedfordshire LU5 5XF; UK LU5 5XF
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohunteligh house; houghton hall business park; houghton regis, bedfordshire LU5 5XF; UK LU5 5XF
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3799163
• MDR Text Key: 4381933
• Report Number: 1000381138-2014-00006
• Device Sequence Number: 1
• Product Code: FNM
• 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: Replace
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 04/07/2014
• Type of Device Usage: Reuse
• Patient Sequence Number: 1