MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-07-19 for SILVER OSTEOTOME, CURVED LEFT RH1462-002 manufactured by Cardinal Health.
[417897]
Tip broke off in the patient's nose. Customer called asking if the item could be felt inside the patient. Customer nose swelled, tip had to be removed by the hospital. Additionally, the account stated that the physician was doing a rhinoplasty on a patient when the tip broke off the osteotome and was left inside of the patient. The patient was sent to x-ray and the broke was located inside of their nose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2005-00095 |
| MDR Report Key | 621839 |
| Report Source | 05 |
| Date Received | 2005-07-19 |
| Date of Report | 2005-07-18 |
| Date of Event | 2005-06-20 |
| Date Mfgr Received | 2005-06-20 |
| Device Manufacturer Date | 1988-10-01 |
| Date Added to Maude | 2005-07-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD, BLDG KB |
| Manufacturer City | MAGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILVER OSTEOTOME, CURVED LEFT |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2005-07-19 |
| Model Number | RH1462-002 |
| Catalog Number | RH1462-002 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 611487 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Baseline Brand Name | SILVER OSTEOTOME LEFT |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | RH1462-002 |
| Baseline Catalog No | RH1462-002 |
| Baseline ID | NA |
| Baseline Device Family | INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-07-19 |