MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-30 for NECK ORTHOSIS 14-103A-00 manufactured by Deroyal Intercontinental , S.r.l.
[110046938]
A call/complaint was received indicating the "cracked under the chin area". The sample has not been received at this time to be able to complete a thorough investigation. The issue was reported as being identified before actual use of the product. The device history record was reviewed and no issues were found. 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, (b)(4) 2016 - (b)(4) 2018 there have been a total of 11 collars reported to be malfunctioning for a percentage of (b)(4) units sold, of this product (b)(4) neck orthosis, semi-rigid. 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
[110046939]
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? 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: cracked under chin. How was the quality issue was identified? By visual inspection. How was the product being used? Neck 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: n/a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2018-00005 |
| MDR Report Key | 7553772 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-30 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-05-01 |
| Date Added to Maude | 2018-05-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | NECK ORTHOSIS |
| Generic Name | ORTHOSIS, CERVICAL |
| Product Code | IQK |
| Date Received | 2018-05-30 |
| Returned To Mfg | 2018-06-28 |
| Model Number | 14-103A-00 |
| Lot Number | 45639676 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other | 2018-05-30 |