MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB BREEZE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Material Puncture/Hole (1504)

Patient Problem Laceration(s) (1946)

Event Date 09/11/2018

Event Type  Injury  

Event Description

Arjo was informed about an incident involving arjo breeze mattress.It was reported that tubing from the mattress located at the foot section protruded through the mattress cover.A patient was rolled to left side for personal care and when rolled back a laceration to patient's left calf was noticed.The patient treatment included use of steri strips which was supported with an external bandage to protect the wound.

Manufacturer Narrative

This report is resubmitted as per the request by mdr data systems team, center for devices and radiological health.This report is being filed under exemption e2012066 by the getinge suzhou ltd (registration #3005619970) on behalf of the importer arjohuntleigh inc (ahus) (registration #1419652).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjohuntleigh, a branch of arjo ltd.Med ab (under registration #3003984900).As of 2011, that number was de-activated due to the site no longer being a manufacturer and shipping product to the usa and until 2014 complaints related to these products were handled by arjohuntleigh, a branch of arjo limited med ab and any medwatch reports were submitted under registration #1000381138.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and medwatch reports might have been submitted under registration #3007420694.Currently any medwatch reports will be submitted under registration #3005619970.Additional information will be provided upon conclusion of the investigation.

• Brand Name: BREEZE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house; houghton hall business park; houghton regis, bedfordshire, LU5 5 XF; TC LU5 5XF
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house; houghton hall business park; houghton regis, bedfordshire, LU5 5 XF; TC LU5 5XF
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 8023131
• MDR Text Key: 317026137
• Report Number: 3007420694-2018-00208
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 09/11/2018
• Supplement Dates FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR
• Patient Sex: Female