MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-12-27 for EZ WRAP 00EZ4-L manufactured by Professional Products.
[20840686]
When surgeon was opening casting material to use in pt, he discovered a pin line object measuring about 1" long (silver colored) with blunt ends. Pt was not injured. Company was notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004845 |
| MDR Report Key | 973667 |
| Date Received | 2007-12-27 |
| Date of Report | 2007-12-27 |
| Date of Event | 2007-12-18 |
| Date Added to Maude | 2008-01-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZ WRAP |
| Generic Name | EZ WRAP CASTING MATERIAL |
| Product Code | ITG |
| Date Received | 2007-12-27 |
| Returned To Mfg | 2007-12-27 |
| Model Number | 00EZ4-L |
| Lot Number | NONE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 943952 |
| Manufacturer | PROFESSIONAL PRODUCTS |
| Manufacturer Address | 54 HIGH ADAMS RD DEFUNK SPRINGS FL 32435 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-27 |