MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2007-08-15 for MALLET 00015500200 manufactured by Zimmer, Inc..
[663587]
It is reported that surgery was performed in 2007. After surgery, the surgeon found that part of the mallet was damaged. An x-ray showed that the mallet fragment remained in the pt. The surgeon plans to observe the pt's progress. No surgery has been scheduled to remove fragment.
Patient Sequence No: 1, Text Type: D, B5
[8130103]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2007-00270 |
| MDR Report Key | 898108 |
| Report Source | 01,05,08 |
| Date Received | 2007-08-15 |
| Date of Report | 2007-07-19 |
| Date of Event | 2007-07-18 |
| Date Mfgr Received | 2007-07-19 |
| Device Manufacturer Date | 1995-06-01 |
| Date Added to Maude | 2009-06-26 |
| 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 Contact | CONNIE MORGAN |
| Manufacturer Street | PO BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5743724269 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALLET |
| Generic Name | INSTRUMENT |
| Product Code | HXL |
| Date Received | 2007-08-15 |
| Returned To Mfg | 2007-08-10 |
| Model Number | NA |
| Catalog Number | 00015500200 |
| Lot Number | 65877300 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | PO BOX 708 WARSAW IN 46581070 US 46581 0708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-15 |