MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-01-31 for DEROYAL 1117PP manufactured by Deroyal Industries, Inc..
[66218906]
Investigation findings: the complaint call states that the "collar cracked under chin. " the complaint call did not specify if the collar was broken during application on a patient. The sample was received by qc investigator. The collar was indeed cracked under chin. There was no lot provided for this sample. This part is molded from the polypropylene (pp) resin. A capa investigation ((b)(4)) was performed for similar complaints in 2015. As a result, the polypropylene (pp) resin raw material was changed to improve the robustness of this part. The first lot of this product that incorporated molded pieces with this new polypropylene resin was manufactured on 01/27/2016 (lot 41545015). Based on visual inspection it looks like this collar might have been manufactured before changes were implemented. However, not lot number was provided therefore, the investigators are unable to verify this. As of 01/19/2017, only one complaint call for this type of failure has been received, for product manufactured after the corrective action, was implemented. The sample was reported to have been damaged during shipping and not on patient or during application to patient. All other complaints, except one, were verified to be for product manufactured before the corrective action. One was unverified because no lot numbers or sample was provided. The complaints to sales ratio for all part numbers of this product in 2016 (this product is sold under 7 different part numbers), was 0. 00012. In 2015 this ratio was 0. 00021. This is half of what it was before the corrective action was implemented. Deroyal will continue to monitor trends for this type of issue and take action if a new trend develops. Root cause: this product malfunction is a known issue that was resolved by corrective action. This product may have been manufactured before the corrective action was implemented, but it cannot be 100% verified. Corrective action: there is no corrective action needed at this time. Preventive action: there is no corrective action needed at this time. No further information is available at this time. We will provide follow up report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[66218907]
Date of occurrence: (b)(6) 2017. 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. Did the quality issue cause a delay in the medical procedure? Not applicable. Detailed description of quality issue: plastic piece in the front of the collar broke. How was the quality issue was identified? By visual inspection. How was the product being used? As intended. Was it the initial use of the product? Yes. Was the product modified from the original condition supplied by deroyal? No. 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 injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2017-00002 |
| MDR Report Key | 6291354 |
| Report Source | USER FACILITY |
| Date Received | 2017-01-31 |
| Date of Report | 2016-12-30 |
| Date Mfgr Received | 2017-01-17 |
| Date Added to Maude | 2017-01-31 |
| 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. ELIZABETH REED |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621256 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | KM7 AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BUILDING 18 |
| Manufacturer City | SANTIAGO, DOMINICAN REPUBLIC |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | CEVICAL COLLAR |
| Product Code | IQK |
| Date Received | 2017-01-31 |
| Returned To Mfg | 2017-01-23 |
| Model Number | 1117PP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | KM7 AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BUILDING 18 SANTIAGO, DOMINICAN REPUBLIC DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-31 |