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

Catalog Number UNK_MED

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 06/13/2017

Event Type  Injury  

Event Description

It was reported that the footrest of the recliner opened too forcefully, hitting a nurse in the shin and causing her to fall over.It was further reported that details of her injuries and any possible medical intervention related to this incident were unknown.No patient involvement and no adverse consequence or clinically relevant delay in treatment for a patient was reported, and no further information regarding the alleged incident were given at this time.

Manufacturer Narrative

It was alleged that a nurse had been down on her hands and knees when she pulled the recliner lever and the footrest hit her in the chin.It was not reported if the nurse recieved medical treatment following the event.This issue was resolved for the customer by following up with the customer to ensure that no further assistance was needed.Unit was not identified for evaluation.

Event Description

It was reported that the footrest of the recliner opened too forcefully, hitting a nurse in the shin and causing her to fall over.It was further reported that details of her injuries and any possible medical intervention related to this incident were unknown.No patient involvement and no adverse consequence or clinically relevant delay in treatment for a patient was reported, and no further information regarding the alleged incident were given at this time.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6708615
• MDR Text Key: 79885292
• Report Number: 0001831750-2017-00294
• 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: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2017
• 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