MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2005-06-01 for HALL STERUM SAW (PENUMATIC) 00505900500 manufactured by Linvatec Corp..
[383032]
This device was attached to the universal hose when the hose burst. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2005-00106 |
| MDR Report Key | 615952 |
| Report Source | 06,07 |
| Date Received | 2005-06-01 |
| Date of Report | 2005-05-03 |
| Date of Event | 2005-05-03 |
| Date Mfgr Received | 2005-05-03 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2005-06-23 |
| 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 | ROGER MURPHY |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995205 |
| Manufacturer G1 | LINVATEC CORPORATION |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALL STERUM SAW (PENUMATIC) |
| Generic Name | STERNUM SAW PNEUMATIC |
| Product Code | KFK |
| Date Received | 2005-06-01 |
| Returned To Mfg | 2005-06-16 |
| Model Number | NA |
| Catalog Number | 00505900500 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 605694 |
| Manufacturer | LINVATEC CORP. |
| Manufacturer Address | * LARGO FL * US |
| Baseline Brand Name | HALL STERNUM SAW (PNEUMATIC) |
| Baseline Generic Name | STERNUM SAW PNEUMATIC |
| Baseline Model No | NA |
| Baseline Catalog No | 00505900500 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K801737 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-06-01 |