MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-15 for EZ WRAP OOEZ4-L manufactured by Professional Products.
[15189061]
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. Patient was not injured. Company was notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005004 |
| MDR Report Key | 981890 |
| Date Received | 2008-01-15 |
| Date of Report | 2007-12-27 |
| Date of Event | 2007-12-18 |
| Date Added to Maude | 2008-01-29 |
| 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 | 2008-01-15 |
| Returned To Mfg | 2007-12-27 |
| Model Number | OOEZ4-L |
| Lot Number | NONE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 952132 |
| Manufacturer | PROFESSIONAL PRODUCTS |
| Manufacturer Address | 54 HUGH ADAMS RD DEFUNK SPRINGS FL 32435 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-15 |