MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-06-22 for BALLENGER SWIVEL KNIFE RH761 manufactured by Allegiance Healthcare Corporation.
[172912]
During nasal surgery, the blade of instrument came off and was lodged in pt's internal nasal mucosa. Blade was noticed missing when instrument was being processed in central supply after the procedure was completed. Pt was in recovery room at the time this was discovered and was taken back for x-rays and surgery for removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2000-00164 |
| MDR Report Key | 283001 |
| Report Source | 05,06 |
| Date Received | 2000-06-22 |
| Date of Report | 2000-06-22 |
| Date of Event | 2000-06-15 |
| Date Mfgr Received | 2000-06-19 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2000-06-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475783636 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLENGER SWIVEL KNIFE |
| Generic Name | SWIVEL KNIFE |
| Product Code | EMF |
| Date Received | 2000-06-22 |
| Returned To Mfg | 2000-06-21 |
| Model Number | RH761 |
| Catalog Number | RH761 |
| Lot Number | R |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 273862 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORPORATION |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | BALLENGER SWIVEL KNIFE |
| Baseline Generic Name | SWIVEL KNIFE |
| Baseline Model No | RH761 |
| Baseline Catalog No | RH761 |
| 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 | 2000-06-22 |