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 EMT SELECT ADULT 0302 manufactured by Deroyal Intercontinental , S.r.l.
[109910502]
A call/complaint was received indicating the "chin piece cracked". Pictures of the product was received and analyzed the reported issue was confirmed. The device history record was reviewed and no issues were found. Inventory was inspected and no issues were found. Although, at this time, a definitive root cause could not be determined after examination of all available information, a potential root cause could be that the section could allow a weakness that may lead to the whole middle section cracking. As corrective action another improvement was made to the mold by adding more plastic to the middle section. This will give more strength and robustness to this area. The improvement was made 06/2/2017 to the area around the rivet hole. It was thickened in that area and support ribs where added. Qc manager in conjunction with operations manager, molding supervisor, molding technician and production manager evaluated 50 pieces processed with the new mold by completely assembly them and it was concluded that the pieces were stronger. The actions taken were verified effective in september 2017 and it was determine that this reported lot number 41910191 was produced in nov 2016, before the actions taken being verified effective. Between, january 1, 2017 - may 23, 2018 there have been a total of 1 collar reported to be malfunctioning for a percentage of (b)(4) units sold, of this product 0302 emt select adult. This 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
[109910503]
*** 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? Yes. Name of medical procedure: application of cervical collar. Did the quality issue cause a delay in the medical procedure? No (please provide length of delay and any other details about the procedure in the detailed description field below). Detailed description of quality issue: do not know if this caused a delay. Chin piece cracked. Detailed email to follow this qfi entry. How was the quality issue was identified? By actual use. How was the product being used? Applied to patient. 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: other. Person(s) affected by outcome(s) checked above: other. 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: outcome and person affected is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2018-00004 |
| MDR Report Key | 7553763 |
| 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 | 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMT SELECT ADULT |
| Generic Name | ORTHOSIS, CERVICAL |
| Product Code | IQK |
| Date Received | 2018-05-30 |
| Returned To Mfg | 2018-05-25 |
| Model Number | 0302 |
| Lot Number | 41910191 |
| 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 | 2018-05-30 |