MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-23 for DEROYAL M7035-S 11342 manufactured by Deroyal Industires, Inc..
[22958084]
Investigation findings: the complaint sample was returned and inspected by the quality control investigator. The product was well worn. The material/body was damaged from wear and use. This included wearing down of the stay pocket resulting in the stay coming out. This product, m7035-s, is a pediatric elbow positioner/immobilizer is intended to be prescribed by a properly licensed practitioner to provide comfortable support while helping prevent patients from pulling i. V. Lines, nasogastric (ng) tubes and tracheostomy tubes. It is a type of restraint and it is contraindicated for a patient who is or may become highly aggressive or agitated. Based on the type of wear is seems to have been misused as a support brace by the end user or user facility. This would also contribute to the damage seen. In the complaint text it was also recorded that the therapist suggested that the original product was too short and allowed the patient to move her arms too much. A larger size product was requested as a replacement. It specifically asked for the larger size product # m7035-l. Correction: a larger size replacement was sent. Root cause analysis: it is concluded that excess wear, misuse and, improper fitting of product when it was issued resulted in material breakdown. Corrective action and/or systemic correction action taken: no action is required at this time since no manufacturing defect was found. Preventive action: no action is required at this time since no manufacturing defect was found.
Patient Sequence No: 1, Text Type: N, H10
[22958085]
This complaint is on product number m7035-s. This is a pediatric elbow positioner/immobilizer is intended to be prescribed by a properly licensed practitioner to provide comfortable support while helping prevent patients from pulling i. V. Lines, nasogastric (ng) tubes and tracheostomy tubes. It is a type of restraint and it is contraindicated for a patient who is or may become highly aggressive or agitated. The customer reported that "metal stays have come out of material pockets and patient has cuts on her forearm and biceps. " the patient had cuts from the stays were treated with topical ointment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010452421-2015-00009 |
| MDR Report Key | 4936809 |
| Date Received | 2015-07-23 |
| Date of Report | 2015-07-22 |
| Date of Event | 2015-07-01 |
| Date Facility Aware | 2015-07-01 |
| Report Date | 2015-07-01 |
| Date Reported to Mfgr | 2015-07-01 |
| Date Mfgr Received | 2015-07-01 |
| Date Added to Maude | 2015-07-23 |
| 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 TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621013 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | KM 20.5 CARRETERA A VILLA CANA |
| Manufacturer City | VILLA CANALES, 01065 |
| Manufacturer Country | GT |
| Manufacturer Postal Code | 01065 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEROYAL |
| Generic Name | ELBOW POSITIONER AND IMMOBILIZER WITH METAL STAYS |
| Product Code | ILI |
| Date Received | 2015-07-23 |
| Returned To Mfg | 2015-07-14 |
| Model Number | M7035-S |
| Catalog Number | 11342 |
| Lot Number | 39173312 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTIRES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-23 |