MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-12-23 for PRESSURE MONITOR 0295-001-000 NA manufactured by Stryker Instruments.
[117392]
When a young man arrived at the hospital after a football accident, measurements taken with the monitor gave readings lower than those taken by the anesthetist in the operating room. A fasciotomy was performed on the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1811755-1998-00061 |
| MDR Report Key | 206576 |
| Report Source | 06 |
| Date Received | 1998-12-23 |
| Date of Report | 1998-12-11 |
| Date Facility Aware | 1998-10-12 |
| Report Date | 1998-11-04 |
| Date Mfgr Received | 1998-11-04 |
| Device Manufacturer Date | 1997-06-01 |
| Date Added to Maude | 1999-01-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESSURE MONITOR |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LXC |
| Date Received | 1998-12-23 |
| Returned To Mfg | 1998-12-11 |
| Model Number | 0295-001-000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 200514 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US |
| Baseline Brand Name | PRESSURE MONITOR |
| Baseline Generic Name | EXPANDER,SKIN,INFLATABLE |
| Baseline Model No | 0295-001-000 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | PRESSURE MONITOR |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K844214 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-12-23 |