MAUDE Adverse Event Report: XIAMEN WORLD GEAR SPORTS GOODS CO., LTD DRIVE DEVILBISS HEALTHCARE; BARIATRIC BED

Model Number	P503
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bed by the provider who stated the bed was missing a cover on the endcap of the metal bed frame.The end user received a cut to their shin that required stitches when they fell under the bed and caught their leg on the edge.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: BARIATRIC BED
• Manufacturer (Section D): XIAMEN WORLD GEAR SPORTS GOODS CO., LTD; 27-29 north 2nd road; xiamen, fujian 36102 2; CH 361022
• MDR Report Key: 19763898
• Report Number: 2438477-2024-00036
• Device Sequence Number: 15581741
• Product Code: OSI
• UDI-Device Identifier: 00822383982823
• UDI-Public: 00822383982823
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2024
• Report Date (Section F): 07/17/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: P503
• Device Catalogue Number: P503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/21/2022
• Event Location: Home
• Date Report to Manufacturer: 07/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Date Report Sent to FDA: 07/17/2024