MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-28 for DEROYAL 14-103A-00 manufactured by Deroyal Intercontinental , S.r.l.
[112887574]
A call/complaint was received indicating the "plastic piece that sits under the chin has snapped in half. A picture of the sample was received and evaluated by the manufacturing plant. The root cause was unable to be determined at this time. The raw material used to produce this product was reviewed and no issues were found. The qc manager tried to reproduce the failure mode by using a finished good product and was unable to duplicate the issue that was reported. The returned sample has been forwarded to the injection molding manager and engineering for further evaluation. Once additional information has been received the complaint will be reopened and the investigation findings will be updated as necessary. Between, (b)(6) 2016 - (b)(6) 2018, there have been a total of 12 collars reported to be malfunctioning for a percentage of (b)(4) units sold, of this product 14-103a-00 neck orthosis, semi-rigid. No further information is available at this time. We will provide a follow up report when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[112887575]
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? 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: the plastic piece that sits under the chin has snapped in half. How was the quality issue was identified? By visual inspection. How was the product being used? The product was being used post injury. 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: they just had to replace the broken collar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2018-00006 |
| MDR Report Key | 7645704 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-28 |
| Date of Report | 2018-06-07 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-06-07 |
| Date Added to Maude | 2018-06-28 |
| 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 |
| 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 | 2018-06-28 |
| Returned To Mfg | 2018-06-12 |
| Model Number | 14-103A-00 |
| Lot Number | 45527113 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-06-28 |