DEROYAL 14-103A-98

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-12-20 for DEROYAL 14-103A-98 manufactured by Deroyal Intercontinental , S.r.l.

Event Text Entries

[131935343] A call/complaint was received indicating the collar was "cracked under chin" before use and there were no injury reported. A picture of the sample was received. The work order number was provided and reviewed, no issues were found. The reported work order was determined to have been manufactured prior to the corrective actions. Engineering completed testing on sample product and found during the backward bend test the pediatric collar failed at an average displacement of 3. 83mm. Whereas in the forward bend test, the pediatric collar was able to reach 10mm of displacement without breaking. In conclusion, the bridge of the collars are most likely failing, when bent backwards, as was performed in the backward bend test. This information displays what will happen if the product is used incorrectly or has excessive force applied. This does not demonstrate what may happen if the product is used as intended. Based on the testing performed by the engineering department, the product will perform properly if used as intended and no excessive force is applied during application or use. Based on the testing completed and conclusion reached by all concerned departments, communication was sent outlining plans to move forward with a change to the resin in order to safeguard against possible misuse or force beyond the breaking point of the material during unusual application. This resin change was implemented on october 25, 2018. The investigation is complete at this time. We will provide a follow up report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[131935344] Quality issue information: product details: product id: 14-103a-98 - neck orthosis, semi-rigid, lot/serial #: (b)(4) warning - not found in (b)(4), quantity: 1 ea, gtin: (b)(4), deroyal sales order #: not entered. Quality issue details: date of occurrence: (b)(6) 2018; when did quality issue occur? Before use; who was using or operating the product when the quality issue occurred? Health professional; 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: cracked under chin; how was the quality issue was identified? By visual inspection; how was the product being used? Neck brace; 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: none, 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: no.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006851902-2018-00010
MDR Report Key8184979
Report SourceOTHER
Date Received2018-12-20
Date of Report2018-11-29
Date of Event2018-11-29
Date Mfgr Received2018-11-29
Date Added to Maude2018-12-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameNECK ORTHOSIS
Product CodeIQK
Date Received2018-12-20
Model Number14-103A-98
Device AvailabilityY
Device Eval'ed by MfgrN
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 2018-12-20

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