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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOERNS HEALTHCARE WECARE RESPONSE BED PATIENT MANUAL BED

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JOERNS HEALTHCARE WECARE RESPONSE BED PATIENT MANUAL BED Back to Search Results
Model Number WECC-WECARE-BASE
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  Injury  
Manufacturer Narrative
This report or other information submitted by joerns healthcare under 21 cfr part 803, and release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare , its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.
 
Event Description
It was reported to the manufacturer, by the end user, per the end user, that (b)(6) called in on behalf of customer and said that they didn't receive the hardware for the f14scal rails. After speaking with product support, there are not any additional hardware that needs to be attached. The patient's daughter said that because of the assist rails not being attached, her mother fell out of the bed. Complaint # (b)(4) was entered into our system.
 
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Brand NameWECARE RESPONSE BED
Type of DevicePATIENT MANUAL BED
Manufacturer (Section D)
JOERNS HEALTHCARE
avenida pedro hinojosa no. 26
cuidad industrial
matamoras, tamaulipas 87499
MX 87499
Manufacturer (Section G)
JOERNS HEALTHCARE
avenida pedro hinojosa no. 26
cuidad industrial
matamoras, tamaulipas 87499
MX 87499
Manufacturer Contact
mackenzie bay
2100 design road
arlington, TX 76014
8008260270
MDR Report Key12931682
MDR Text Key281734017
Report Number3009402404-2021-00022
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWECC-WECARE-BASE
Device Catalogue NumberWECC-WECARE-BASE
Was Device Available for Evaluation? No
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/05/2021 Patient Sequence Number: 1
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