MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-25 for LOWSLEY TRACTOR 437 * manufactured by Acmi Corp..
[348174]
Lowsley tractor failed to close during operative procedure requiring dissassembly to close and safely remove from pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034419 |
| MDR Report Key | 568148 |
| Date Received | 2005-01-25 |
| Date of Report | 2005-01-25 |
| Date of Event | 2005-01-18 |
| Date Added to Maude | 2005-01-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOWSLEY TRACTOR |
| Generic Name | UROLOGICAL INSTRUMENT |
| Product Code | KDA |
| Date Received | 2005-01-25 |
| Model Number | 437 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 557976 |
| Manufacturer | ACMI CORP. |
| Manufacturer Address | 136 TURNPIKE RD SOUTHBOROUGH MA 017722104 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-01-25 |