MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TREATMENT RECLINER; CHAIR, EXAMINATION AND TREATMENT

Catalog Number 3500000710

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 03/30/2015

Event Type  Injury  

Event Description

It was reported a patient cut their leg on the recliner mechanism.The unit was evaluated by a stryker service technician, who found there was no malfunction or defect with the unit.

Manufacturer Narrative

A visual and functional inspection was performed by a stryker service technician.It was found that no components were damaged or missing and the unit was working to specifications.The patient is a female in her (b)(6)s who weighs approximately (b)(6) pounds.The patient is diabetic and on heavy anti-coagulant medications causing her skin to be very thin.The injury occurred when the patient moved her leg off from the footrest to allow the caregiver to close the recliner.When the recliner was closed it pinched the patient¿s calf between the footrest, seat section, and arm section which tore the skin.The wound required approximately 12 stitches.The director of nursing and wound care at the user facility reports this was an accident resulting from the caregiver not ensuring the patient was clear of all pinch-point and it was not resulting from a defect or malfunction of the chair.

Event Description

It was reported a patient cut their leg on the recliner mechanism.No additional information regarding the severity of the alleged injury is known.

• Brand Name: TREATMENT RECLINER
• Type of Device: CHAIR, EXAMINATION AND TREATMENT
• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4733972
• MDR Text Key: 20031943
• Report Number: 0001831750-2015-00188
• Device Sequence Number: 1
• Product Code: FRK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 3500000710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2015
• 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
• Patient Outcome(s): Life Threatening