MAUDE Adverse Event Report: SIZEWISE WORLDWIDE SIZEWISE PSYCH HOSPITAL BED; BED, MANUAL

Model Number HOSPITAL PSYCH BED

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 05/03/2018

Event Type  Injury  

Event Description

Safety screws on sizewise psych hospital bed were loose.Pt was able to remove 2 screws from interior head siderail.The screws were swallowed by the patient which required surgery for removal.All beds were checked.Several beds found to have loose screws.All screws on all sizewise psych beds were attached with adhesive and tightened to bed.

• Brand Name: SIZEWISE PSYCH HOSPITAL BED
• Type of Device: BED, MANUAL
• Manufacturer (Section D): SIZEWISE WORLDWIDE; 8601 monrovia st.; lenexa KS 66215
• MDR Report Key: 7553258
• MDR Text Key: 109679907
• Report Number: MW5077517
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HOSPITAL PSYCH BED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 25 YR