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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRAFTMATIC INDUSTRIES, INC. CRAFTMATIC MODEL 1 BASE; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

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CRAFTMATIC INDUSTRIES, INC. CRAFTMATIC MODEL 1 BASE; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE Back to Search Results
Model Number 4AR792
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Fall (1848)
Event Date 07/12/2019
Event Type  Injury  
Manufacturer Narrative
Unique id# (b)(4).After speaking with the customer's partner, (b)(6), she confirmed that when she transferred the customer into bed she pushed the bed causing the bed to move away and the customer to fall.(b)(6) confirmed that the installation was done correctly and that prior to the incident all casters were in caster cups.(b)(6) states that the customer has been admitted to hospice because she is terminally ill, and requires additional assistance that cannot be offered at home, per delivery manager- (b)(4).Based on the information provided by the customer; the complaint is reportable per cfr 21 803.3.Mdr 2018-00010.
 
Event Description
Bed was purchased friday 05 july, 2019; bed was delivered 07/11/2019.Received a message from a sales representative; (b)(4).Sales representative states that (b)(6), customer's partner, states that while attempting to assist the customer into bed, the bed slid 5 feet away from the customer causing her to fall.(b)(6), mrs (b)(6)'s partner, confirmed the castor wheels were locked at time of incident and that after the bed slipped they advised the castor cups were scattered all over the floor.(b)(6) states that the customer weighs (b)(6) and uses a walker to get around.(b)(6) confirms that no medial attention was sought due to fall.Mrs.(b)(6) requires the assistance of others to get in and out of bed, chairs and cars.
 
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Brand Name
CRAFTMATIC MODEL 1 BASE
Type of Device
BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
Manufacturer (Section D)
CRAFTMATIC INDUSTRIES, INC.
5192 sw 27th ave
ft. lauderdale FL 33312
Manufacturer (Section G)
CRAFTMATIC INDUSTRIES, INC.
5192 sw 27th ave
ft. lauderdale FL 33312
Manufacturer Contact
jessica vivar
5192 sw 27th ave
ft. lauderdale, FL 33312
9548280893
MDR Report Key8880424
MDR Text Key154108632
Report Number3008872045-2019-00010
Device Sequence Number1
Product Code LLI
Combination Product (y/n)N
PMA/PMN Number
K022387
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Remedial Action Inspection
Type of Report Initial
Report Date 08/05/2019
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? No
Device Operator Lay User/Patient
Device Model Number4AR792
Device Catalogue NumberCMMOD1
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/17/2019
Initial Date FDA Received08/09/2019
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 Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Weight86
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