MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-12-12 for DEROYAL 13662067 manufactured by Deroyal Industries, Inc..
[62182361]
The materials of construction were reviewed. The abdominal binder part number (b)(4) is composed of six raw materials. When used as intended, only four of these would touch the patient's skin. These are: (b)(4). These are components used in the construction of this product are commonly used in textiles found in commercially available articles of clothing, furniture, and other deroyal bracing products. They do not contain natural rubber latex.. These raw materials also have all been evaluated through the internal raw material procurement and review process. As a result, it has been determined by this process that this item contains no chemicals of concern as defined as: "mercury, cadmium, lead, pvc, phthalate (plasticizers), flame retardant chemicals, persistent bioaccumulative toxic compounds, carcinogenic and reproductive toxins or "renewable materials" (products made from resources that are not depleted by human use, such as corn and soybeans or other biobased polymers)," from information provided by our vendors. The complaint sample was not returned, and the lot number was not listed. There were no details provided as to where the hives were located (was it on a specific section of the abdomen or back or was it over entire area product covered). No root cause could be determined, therefore no corrective action or preventive action can be implemented 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
[62182362]
When did quality issue occur: during use. Who was using or operating the product when the quality issue occurred: patient/end consumer. Detailed description of quality issue: patient wore for 5 days after surgery and broke out in severe hives. Hives subsided but did not go away. Patient is taking antihistamines and steroids to control hives. How was the quality issue was identified: by actual use. How was the product being used: as directed. Was it the initial use of the product: yes. Was the product modified from the original condition supplied by deroyal: no. Outcome(s) attributed to quality issue: irritation, reaction, rash details of irritation, reaction, rash (severity, medical treatment, etc. ): severe hives over all exposure sites. 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: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010452421-2016-00022 |
| MDR Report Key | 6167406 |
| Report Source | CONSUMER |
| Date Received | 2016-12-12 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-11-14 |
| Date Mfgr Received | 2016-11-14 |
| Date Added to Maude | 2016-12-12 |
| 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. 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 | KM 20.5 CARRETERA A VILLA CANALES |
| Manufacturer City | VILLA CANALES, GUATEMALA 01065 |
| Manufacturer Country | GT |
| Manufacturer Postal Code | 01065 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | ABDOMINAL BINDER |
| Product Code | FSD |
| Date Received | 2016-12-12 |
| Model Number | 13662067 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | KM 20.5 CARRETERA A VILLA CANALES VILLA CANALES, GUATEMALA 01065 GT 01065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-12 |