MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-17 for LASERFLO BPM2 manufactured by Vasamedics L.l.c..
[21397009]
On 2/11/97 the blood perfusion monitor was used post operatively to measure blood flow on a muscle flap transplant on a 39 yr old male pt. The muscle flap failed yet the monitor indicated some blood flow. The monitor was tested at the plastic surgery lab immediately after the case with no trouble found. The monitor has not yet been returned to the mfr for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183929-1997-00001 |
| MDR Report Key | 76826 |
| Date Received | 1997-03-17 |
| Date of Report | 1997-03-10 |
| Date of Event | 1997-02-11 |
| Date Mfgr Received | 1997-02-14 |
| Device Manufacturer Date | 1991-07-01 |
| Date Added to Maude | 1997-03-20 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LASERFLO |
| Generic Name | LASER DOPPLER BLOOD FLOW MONITOR |
| Product Code | DPW |
| Date Received | 1997-03-17 |
| Model Number | BPM2 |
| Catalog Number | BPM2 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 76548 |
| Manufacturer | VASAMEDICS L.L.C. |
| Manufacturer Address | 2963 YORKTON BLVD. ST PAUL MN 55117 US |
| Baseline Brand Name | LASERFLO BLOOD PERFUSION MONITORING SYSTEM |
| Baseline Generic Name | LASER DOPPLER BLOOD PERFUSION MONITORING SYSTEM |
| Baseline Model No | BPM2 |
| Baseline Catalog No | BPM2 |
| Baseline ID | BPM2 MONITOR AN |
| Baseline Device Family | LASER DOPPLER BLOOD PERFUSION MONITORING SYSTEM |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K912446 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 1997-03-17 |