DEROYAL 1044-31

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-02 for DEROYAL 1044-31 manufactured by Deroyal Intercontinental , S.r.l.

Event Text Entries

[107732353] A call/complaint was received indicating the "brace broke while they were using it". The sample has not been received at this time to be able to complete a thorough investigation. The device history record was not able to be reviewed due to no lot number being provided. Inventory was inspected and no issues were found. The root cause was unable to be determined, due to the absence of the sample the investigator could not confirm the reported issue. If a sample is received the complaint will be reopened and updated as necessary. Between, september 16, 2016 - april 25, 2018, there have been a total of 25 collars reported to be malfunctioning for a percentage of (b)(4) units sold, of this product 1044-31 cervical collar, emt select, one piece. No further information is available at this time. We will provide a follow up report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[107732354] Quality issue details: date of occurrence: (b)(6) 2018. When did quality issue occur? During use. Who was using or operating the product when the quality issue occurred? Patient/end consumer. Was a medical procedure involved? No. Name of medical procedure: not applicable. Did the quality issue cause a delay in the medical procedure? Not applicable. Detailed description of quality issue: the brace broke while they were using it - that is all the patient told the doctor. How was the quality issue was identified? By actual use. How was the product being used? As directed. Was it the initial use of the product? Yes. 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? No. Outcome details: outcome(s) attributed to quality issue: none. Person(s) affected by outcome(s) checked above: patient. Known pre-existing condition(s) of person(s) affected: none specified. Was the incident reported to the fda? No. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: just needs a new brace.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006851902-2018-00003
MDR Report Key7479313
Report SourceUSER FACILITY
Date Received2018-05-02
Date of Report2018-04-05
Date of Event2018-04-05
Date Mfgr Received2018-04-05
Date Added to Maude2018-05-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. MELISSA LOGSDON
Manufacturer Street200 DEBUSK LANE
Manufacturer CityPOWELL TN 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone8653626157
Manufacturer G1DEROYAL INTERCONTINENTAL , S.R.L
Manufacturer StreetKM 7, AUTOPISTA JOAQUIN BALAGUER, PISANO FREE ZONE, 18
Manufacturer CitySANTIAGO,
Manufacturer CountryDR
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEROYAL
Generic NameCERVICAL COLLAR
Product CodeIQK
Date Received2018-05-02
Model Number1044-31
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEROYAL INTERCONTINENTAL , S.R.L
Manufacturer AddressKM 7, AUTOPISTA JOAQUIN BALAGUER, PISANO FREE ZONE, 18 SANTIAGO, DR


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-02

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