MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-03-23 for NORCO SHOULDER PULLEY NC52069 manufactured by North Coast Medical, Inc..
[2595191]
On (b)(6) 2011, customer was rehabilitating his left shoulder, which had recently undergone surgery, using a norco shoulder pulley given to him by his treating physician. The pulley's wheel snapped, causing the customer to sustain injury. On (b)(6) 2011, the customer presented to an orthopedic practice center. Physician's assistant noted that the customer was working out with his pulley to maintain range of motion after undergoing a left shoulder arthroplasty, when the pulley broke, causing a forced extension injury to the right shoulder. X-rays of the right shoulder revealed a massive, unrepairable rotator cuff tear and spontaneous rupture of the biceps tendon. A glenohumeral joint injection was administered for pain. On (b)(6) 2011, the customer presented to the same orthopedic practice center. The same physician's assistant noted that the customer declined surgery on the right shoulder, so a glenohumeral joint injection was administered. On (b)(6) 2011, the customer presented to the same orthopedic practice center. Physician's assistant noted that the customer underwent a repeat injection of the right shoulder, and that he was markedly debilitated from his injury regarding the pulley. The customer's treating physician has provided a causation letter documenting that he has a probable cuff tear which presently leaves his arm functionally worthless.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939821-2011-00016 |
| MDR Report Key | 2504738 |
| Report Source | 00 |
| Date Received | 2012-03-23 |
| Date of Report | 2012-03-21 |
| Date of Event | 2011-05-30 |
| Date Mfgr Received | 2012-02-23 |
| Date Added to Maude | 2012-03-28 |
| 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 | PRECISION MACHINING, LTD. |
| Manufacturer Street | JIANGLING RD, FLOOR 1, #6 BLDG BINJIANG DIST |
| 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 SHOULDER PULLEY |
| Generic Name | SHOULDER PULLEY |
| Product Code | ION |
| Date Received | 2012-03-23 |
| Model Number | NC52069 |
| Catalog Number | NC52069 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2012-03-23 |