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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL LIMB HOLDER

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DEROYAL INDUSTRIES, INC. DEROYAL LIMB HOLDER Back to Search Results
Model Number M2028
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2016
Event Type  malfunction  
Manufacturer Narrative
Investigation is currently in progress. No further information is available at this time. We will provide follow up report if additional information becomes available.
 
Event Description
When did quality issue occur? during use. Who was using or operating the product when the quality issue occurred? health professional. Was a medical procedure involved? no. Did the quality issue cause a delay in the medical procedure? not applicable. Detailed description of quality issue: the initial blame is being cast on our restraint pulling apart and stretching to the point where the patient could extubate themselves and pull out all of their other lines. How was the quality issue was identified? by actual use. How was the product being used? restraining a patient's wrist in the icu. Was it the initial use of the product? no. Was the product modified from the original condition supplied by deroyal? no. Was the product connected to or used in conjunction with other devices or equipment? yes. Please describe connected equipment type, settings, etc. : icu in a progressive bed. Person(s) affected by outcome(s) checked above: patient. Known pre-existing condition(s) of person(s) affected: icu patient, no specifics were given as to their diagnosis. Was the incident reported to the fda? no. Detailed description of outcome(s), including information regarding injury or any additional treatment/ intervention required: the patient pulled all of their lines out and extubated themselves. Everything had to be put back in, however the patients was released yesterday according to the nurse.
 
Manufacturer Narrative
Investigation findings: according to the picture provided, it has been determined that the problem reported is related to a manufacturing sewing issue. Process records could not be reviewed because no lot number was provided by the customer. Work in process evaluation performed for product on hand at manufacturing facility, does not show any issues. A total of (b)(4) limb holders for the part in reference have been sold from jan/02/15 through jan/23/17 and no complaints due manufacturing issues have been reported for the same period of time. Root cause: sewing error. The bobbin ran out of thread during the process of the work order. Operator did not check previous devices to assure no product with false tacks was completed. Corrections: repairs, reworks, adjustments, reimbursement or replacements. No compensation was requested by the customer. Corrective action: because no lot number was provided to train specific operator for the error made, the current personnel who performs the tacking operation in the line will be informed of the issue. Personnel will be instructed to make sure they check that the devices are not sewn with false tacks when the bobbin runs out of thread and to check previous devices to avoid false tacks. Quality control personnel has been informed of the issue as well, in order to make sure they check that devices from the quality control inspections are not sewn with false tacks. Preventive action: not applicable. Corrective action has been taken due the existing non-conformity from the customer. No further information is available at this time. We will provide follow up report if additional information becomes available. No further information is available at this time. We will provide follow up report if additional information becomes available.
 
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Brand NameDEROYAL
Type of DeviceLIMB HOLDER
Manufacturer (Section D)
DEROYAL INDUSTRIES, INC.
km 20.5 carretera a
villa canales
villa canales, guatemala 01065
GT 01065
Manufacturer (Section G)
DEROYAL INDUSTRIES, INC.
km 20.5 carretera a
villa canales
villa canales, guatemala 01065
GT 01065
Manufacturer Contact
elizabeth reed
200 debusk ln
powell 37849
8653621256
MDR Report Key6254401
MDR Text Key64929542
Report Number3010452421-2017-00001
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM2028
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/16/2017 Patient Sequence Number: 1
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