MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-04 for DEROYAL 14-103A-98 manufactured by Deroyal Intercontinental , S.r.l.
[129764013]
A call/complaint was received indicating the "product arrived with the plastic frame for the chin rest cracked" before use. The work order could not be reviewed because the finished good lot number was not reported. A picture of the sample was received and evaluated by the manufacturing plant. Engineering completed testing on sample product and found during the backward bend test the adult collar failed at an average displacement of 7. 14 mm, and the pediatric collar failed at an average displacement of 3. 83 mm. Whereas in the forward bend test, both the adult and pediatric collars were able to reach 10 mm 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. 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 will serve to further improve the product. Between, january 1, 2016 - december 3, 2018 there have been a total of 1 collar reported to be malfunctioning and (b)(4) units sold for a percentage of (b)(4)%, of this product 14-103a-98 neck orthosis, semi-rigid. 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
[129764014]
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? Not applicable. 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 product arrived with the plastic frame for the chin rest cracked. How was the quality issue was identified? By visual inspection. How was the product being used? Stock for inventory. 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: na.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2018-00009 |
| MDR Report Key | 8128245 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-04 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-11-08 |
| Date Mfgr Received | 2018-11-09 |
| Date Added to Maude | 2018-12-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MELISSA LOGSDON |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626157 |
| Manufacturer G1 | DEROYAL INTERCONTINENTAL , S.R.L |
| Manufacturer Street | KM 7, AUTOPISTA JOAQUIN BALAGUER, PISANO FREE ZONE, 18 |
| Manufacturer City | SANTIAGO, |
| Manufacturer Country | DR |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | NECK ORTHOSIS |
| Product Code | IQK |
| Date Received | 2018-12-04 |
| Returned To Mfg | 2018-11-30 |
| Model Number | 14-103A-98 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INTERCONTINENTAL , S.R.L |
| Manufacturer Address | KM 7, AUTOPISTA JOAQUIN BALAGUER, PISANO FREE ZONE, 18 SANTIAGO, DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-04 |