MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-26 for NORCO DOOR EXERCISE PULLEYS NC52069 manufactured by Welform/wei Fu Precision Machining.
[2707020]
The customer was using the norco over door exercise pulley to help improve the range of motion and coordination. The product comes with a cord, a small plastic pulley mechanism and a handle and its intended for slow, passive stretching. As per customer after using the pulley for a while, the plastic pulley gets hot by touch and burned one of their pts hand when the pt touched the plastic pulley.
Patient Sequence No: 1, Text Type: D, B5
[9997371]
Na.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939821-2011-00004 |
| MDR Report Key | 2640050 |
| Report Source | 05 |
| Date Received | 2011-08-26 |
| Date of Report | 2011-08-22 |
| Date of Event | 2011-06-16 |
| Date Facility Aware | 2011-06-16 |
| Report Date | 2011-08-22 |
| Date Mfgr Received | 2011-06-16 |
| Date Added to Maude | 2012-07-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAN LYNCH |
| Manufacturer Street | 8100, CAMINO ARROYO |
| Manufacturer City | GILROY CA 95020 |
| Manufacturer Country | US |
| Manufacturer Postal | 95020 |
| Manufacturer Phone | 4087765000 |
| Manufacturer G1 | ELFORM/WEI FU PRECISION MACHINING, LTD. |
| Manufacturer Street | FLOOR 1, NO.6 BUILDING 88 JIANGLING ROAD BINJIANG DISTRICT |
| Manufacturer City | HANGZHOU 310051 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 310051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NORCO DOOR EXERCISE PULLEYS |
| Generic Name | OVER DOOR EXERCISE PULLEYS |
| Product Code | ION |
| Date Received | 2011-08-26 |
| Model Number | NA |
| Catalog Number | NC52069 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELFORM/WEI FU PRECISION MACHINING |
| Manufacturer Address | HANGZHOU CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-26 |