MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-06-08 for NORCO EXERCIS LOOP ATTACHMENT NC91231-50 manufactured by North Coast Medical, Inc..
[2767457]
(b)(6) 2009, while vacationing at (b)(6), pt was performing exercises prescribed by optm sports therapy using thera-band exercise 24 bands and a north coast exercise loop (aka the door anchor). While performing the prescribed exercises, the north coast exercise loop snapped through the door and struck pt's left eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939821-2012-00017 |
| MDR Report Key | 2620792 |
| Report Source | 00 |
| Date Received | 2012-06-08 |
| Date of Report | 2012-06-07 |
| Date of Event | 2009-01-07 |
| Date Mfgr Received | 2012-05-11 |
| Date Added to Maude | 2012-06-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 8100 CAMINO ARROYO |
| Manufacturer City | GILROY CA 93101 |
| Manufacturer Country | US |
| Manufacturer Postal | 93101 |
| Manufacturer Phone | 8008219319 |
| Manufacturer G1 | ADVANCE FABRICATION |
| Manufacturer Street | 140 MAST AVE STE B |
| Manufacturer City | MORGAN HILL CA 95037 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95037 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NORCO EXERCIS LOOP ATTACHMENT |
| Generic Name | DOOR ANCHOR |
| Product Code | ION |
| Date Received | 2012-06-08 |
| Model Number | NC91231-50 |
| Catalog Number | NC91231-50 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTH COAST MEDICAL, INC. |
| Manufacturer Address | GILROY CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-06-08 |