MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-06-19 for DYNAREX CPR SHIELD WITH ONE WAY VALVE 4921 manufactured by Danyang Sunmed Healthcare Corp.
[21170689]
Distributor inspected the device and found the labeling on the device, an instruction for use printed on the cpr shield ("this side up"), was printed on the wrong side of the device.
Patient Sequence No: 1, Text Type: D, B5
[21277156]
There were no complaints with this labeling issue in the past. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2431014-2014-00001 |
| MDR Report Key | 4073212 |
| Report Source | 08 |
| Date Received | 2014-06-19 |
| Date of Report | 2014-06-19 |
| Date of Event | 2014-06-04 |
| Date Facility Aware | 2014-06-04 |
| Report Date | 2014-06-19 |
| Date Reported to FDA | 2014-06-19 |
| Date Mfgr Received | 2014-05-12 |
| Date Added to Maude | 2014-09-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | NO. 3 BEI ER HUAN |
| Manufacturer City | DANYANG 212300 |
| Manufacturer Country | CH |
| Manufacturer Postal | 212300 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNAREX CPR SHIELD WITH ONE WAY VALVE |
| Generic Name | CPF FAVE SHIELD |
| Product Code | CBP |
| Date Received | 2014-06-19 |
| Model Number | 4921 |
| Catalog Number | 4921 |
| Lot Number | 28619, 28621 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DANYANG SUNMED HEALTHCARE CORP |
| Manufacturer Address | DANYANG 212300 CH 212300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-19 |