MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-07-15 for DEROYAL 11461000 manufactured by Deroyal Industries, Inc..
[49641823]
Investigation findings: the complaint sample was not available for return, and there was no lot number listed in the complaint information. Product on hand was reviewed at random, there was no manufacturing errors/defects found. The complaint to sales ratio for product rubbing on skin for july 2014 to july 2016 is (b)(4). The investigator followed up with sales representative to inquire on the nature of the "skin breakdown" reported. Skin breakdown is a generic term that could many types of skin injury. The customer verbally relayed the following information to the sales representative. The patient developed pressure sores at the top to the chest and the jaw. These were caught early and patient was equipped with another product. Root cause: investigation team was unable to determine root cause as the complaint sample was not returned. Corrections: credit was requested/issued. Corrective action: there were no manufacturing defects found in house and no root cause was determined, therefore no corrective action is needed at this time. Preventive action: there is no preventive action required 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
[49641824]
The quality issue details and the outcome details section copied below are responses given by the initial reporter to the deroyal complaint questionnaire. Quality issue details: date of occurrence: (b)(6) 2016. 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: patient stated that collar was very uncomfortable where it met the upper chest, skin breakdown was observed. How was the quality issue was identified? By actual use. How was the product being used? Used to immobilize patients head and neck. Was it the initial use of the product? No. 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: irritation, reaction, rash. Details of irritation, reaction, rash (severity, medical treatment, etc. ): skin breakdown. Person(s) affected by outcome(s) checked above: patient. Known pre-existing condition(s) of person(s) affected: none specified. Was the incident reported to the fda? Don't know. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: (b)(6), got a replacement collar to try, patient refused to wear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2016-00009 |
| MDR Report Key | 5797993 |
| Report Source | USER FACILITY |
| Date Received | 2016-07-15 |
| Date of Report | 2016-07-12 |
| Date of Event | 2016-06-12 |
| Report Date | 2016-06-14 |
| Date Reported to Mfgr | 2016-06-14 |
| Date Mfgr Received | 2016-06-14 |
| Date Added to Maude | 2016-07-15 |
| 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 | CERVICAL COLLAR |
| Product Code | IQK |
| Date Received | 2016-07-15 |
| Model Number | 11461000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2016-07-15 |