MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-06-03 for DEROYAL 1044-41 manufactured by Deroyal Industries, Inc..
[46571894]
Investigation findings: in order to mitigate this, the polypropylene (pp) resin used for the molded white chin piece was changed to increase the strength of this part for both the adult (1044-31) and the pediatric collars (1044-41). The first lot of our pediatric emt select extrication collars that incorporated this change was manufactured on 03/17/2016. For current complaint being addressed, the correct lot number was not provided. This means we are unable to track the corresponding sample to determine date of manufacture and therefore whether this was made before or after 03/17/2016. However, we believe this collar was made before the change was implemented. This is the first complaint received for part number 1044-31 after the (b)(4) was implemented. As the new lots of our modified (b)(4) extrication collars go out into the market, deroyal continues to monitor trends for these failure types and will recognize if it becomes a recurring issue. The average complaint/sales ratio for the past two years for this part number is 0. 00009. Root cause: investigators concluded that user error is the likely root cause. The user not handling the collar as intended. When applied as directed, investigators were unable to induce malfunction. However, malfunction could eventually be induced if the collar was bent or rolled tightly enough. This type of handling is not consistent with the instructions. Related mdrs: these mdrs were filed for complaints submitted before the manufacturing change was implemented: 3006851902-2016-00001 (mw5058809), 3006851902-2016-00002, 3006851902-2016-00003, 3006851902-2016-00004. Corrective action: the polypropylene (pp) resin used for the molded white chin piece was changed to increase the strength of this part. The lot of our emt select extrication collars that incorporate this change was manufactured on 01/27/2016. Preventive action: a preventive action is not 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
[46571895]
Date of occurrence: (b)(6) 2016. 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? Was not. Was it the initial use of the product? Yes. Was the product modified from the original condition supplied by (b)(4)? No. Was the product connected to or used in conjunction with other devices or equipment? No. 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 | 3006851902-2016-00008 |
| MDR Report Key | 5698714 |
| Report Source | USER FACILITY |
| Date Received | 2016-06-03 |
| Date of Report | 2016-06-01 |
| Date of Event | 2016-05-11 |
| Report Date | 2016-05-11 |
| Date Reported to Mfgr | 2016-05-11 |
| Date Mfgr Received | 2016-05-11 |
| Date Added to Maude | 2016-06-03 |
| 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 | DR. MARIAN VARGAS |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621013 |
| 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 | EMT CERVICAL COLLAR |
| Product Code | IQK |
| Date Received | 2016-06-03 |
| Returned To Mfg | 2016-05-23 |
| Model Number | 1044-41 |
| Operator | EMERGENCY MEDICAL TECHNICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-03 |