MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-03-15 for DEROYAL 157-01 manufactured by Deroyal Intercontinental, S.r.l..
[3197232]
The medical facility reported that one of cable has frayed causing the end user to stab or poke her fingers.
Patient Sequence No: 1, Text Type: D, B5
[10630031]
Deroyal: return of the sample has been requested. The investigation into the root cause of this report has not been completed at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006851902-2013-00002 |
| MDR Report Key | 3011162 |
| Report Source | 06 |
| Date Received | 2013-03-15 |
| Date of Report | 2013-03-05 |
| Date of Event | 2013-03-05 |
| Date Facility Aware | 2013-03-05 |
| Report Date | 2013-03-05 |
| Date Reported to Mfgr | 2013-03-05 |
| Date Mfgr Received | 2013-03-05 |
| Date Added to Maude | 2013-04-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | DEROYAL INTERCONTINENTAL, S.R.L. |
| Manufacturer Street | KM 7 AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BUILDING 18 |
| Manufacturer City | SANTIAGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | IPY - ORTHOSIS, LUMBO-SACRAL |
| Product Code | IPY |
| Date Received | 2013-03-15 |
| Catalog Number | 157-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INTERCONTINENTAL, S.R.L. |
| Manufacturer Address | DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-15 |