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 NC91223-50 manufactured by Thai Centri Co. Ltd..
[17923588]
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Patient Sequence No: 1, Text Type: N, H10
[18041486]
The pt was doing standing rows with level 3 resistance exercise band. It was a newly cut band and as she was doing the exercise, the band snapped in half. She fell backwards and fell on her hip developing a hematoma. The pt had been coming to therapy since early (b)(6) 2009 with a cervical spine strain and had been doing this exercise for at least 6 visits.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939821-2011-00013 |
| MDR Report Key | 2238392 |
| Report Source | 05 |
| Date Received | 2011-08-26 |
| Date of Report | 2011-08-24 |
| Date of Event | 2009-11-17 |
| Date Facility Aware | 2009-12-10 |
| Report Date | 2011-08-24 |
| Date Mfgr Received | 2009-12-10 |
| Date Added to Maude | 2011-09-09 |
| 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 AARROYO |
| Manufacturer City | GILROY CA 950202845 |
| Manufacturer Country | US |
| Manufacturer Postal | 950202845 |
| Manufacturer Phone | 4087765000 |
| Manufacturer G1 | THAI CENTRI CO. LTD. |
| Manufacturer Street | 44/5 MOO 5, SOI SUWAN SETTHAKIJ ROAD |
| Manufacturer City | KLONGMADUA KRATUNAN SAMUTSAKOR |
| Manufacturer Country | TH |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| 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 | NC91223-50 |
| 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 |