MAUDE Adverse Event Report: MERITS HEALTH INDUSTRIES (SUZHOU) CO.,LTD. MERITS HEALTH INDUSTRIES (SUZHOU) CO.,LTD.; HOSPITAL BED

Model Number B211-3BRMU

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 03/11/2022

Event Type  malfunction  

Event Description

The patient's leg got caught between the mattress and the springs.The legs were scratched and was bleeding.

Manufacturer Narrative

When we (manufacturer) routinely check fda website on mar.11th 2022.For any reported manufacturer and user facility device experience database (maude) on merits products, we found one reporting case that is related to our product, b211 (hospital bed).However; we didn't obtain any contact information of patient until mar.22nd when we received official notice fda letter.This form is submitted in response to fda generated mdr report mw5107746.Our importer has contacted the patient on mar 22nd.We will keep in touch with importer to get more information on the device problem, understand the root cause and take necessary follow-up actions.

• Brand Name: MERITS HEALTH INDUSTRIES (SUZHOU) CO.,LTD.
• Type of Device: HOSPITAL BED
• Manufacturer (Section D): MERITS HEALTH INDUSTRIES (SUZHOU) CO.,LTD.; no. 18, junke rd.; nantun dist.,; taichung, taiwan 40852 ; CH 40852
• Manufacturer (Section G): MERITS HEALTH INDUSTRIES (SUZHOU) CO.,LTD.; no. 18, junke rd.; nantun dist.; taichung, taiwan 40852 ; CI 40852
• Manufacturer Contact: efy cheng ; no. 18, junke rd.; nantun dist.; taichung, taiwan 40852 ; CH 40852
• MDR Report Key: 14250949
• MDR Text Key: 299460539
• Report Number: 9618009-2022-00001
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: B211-3BRMU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White