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 NC EXERCISE BAND, LEVEL 3 NC91221-50 manufactured by Thai Centri Co, Ltd.
[2827449]
Received customer complaint that one of their pt got slapped on the face when a level 3 exercise band snapped.
Patient Sequence No: 1, Text Type: D, B5
[9971966]
Catalog numbers: nc 91223-50 and nc91225-50.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939821-2011-00014 |
| MDR Report Key | 2640028 |
| Report Source | 05 |
| Date Received | 2011-08-26 |
| Date of Report | 2011-08-24 |
| Date of Event | 2009-08-21 |
| Date Facility Aware | 2009-08-21 |
| Report Date | 2011-08-24 |
| Date Mfgr Received | 2009-08-21 |
| Date Added to Maude | 2012-07-10 |
| 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 | THAI CENTRI CO., LTD |
| Manufacturer Street | 44/5 MOO 5, SOI SUWAN, SETTHAKIJ ROAD KLONGMADUA, KRATUNAN |
| Manufacturer City | SAMUTSAKORN 74110 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 74110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NC EXERCISE BAND, LEVEL 3 |
| Generic Name | EXERCISE BAND |
| Product Code | ION |
| Date Received | 2011-08-26 |
| Model Number | NA |
| Catalog Number | NC91221-50 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THAI CENTRI CO, LTD |
| Manufacturer Address | SAMUTSAKORN TH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-26 |