MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SPR PLUS II BED CUSHION

Catalog Number CL212

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Pressure Sores (2326)

Event Date 03/26/2015

Event Type  malfunction  

Event Description

It was reported that patients have allegedly developed pressure ulcers on their feet from the bed footboard.It was also reported that a fitted sheet came off of a spr plus overlay pulling the holding strap and causing the overlay and patient to slide to the floor, no injuries were reported.

Manufacturer Narrative

Follow-up submitted revising the executive summary to only reflect the overlay sliding to the floor.Previous reference to alleged pressure ulcer was removed and will be addressed in a separate report.(b)(4).

Event Description

It was reported that a fitted sheet allegedly came off of a spr plus overlay pulling the holding strap and causing the overlay and patient to slide to the floor, no injuries were reported.

• Brand Name: SPR PLUS II BED CUSHION
• Type of Device: CUSHION
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: rita moffitt ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4720687
• MDR Text Key: 5744991
• Report Number: 0001831750-2015-00175
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2015

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?: Yes
• Device Operator: Other
• Device Catalogue Number: CL212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 04/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1