MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-08-06 for CABLE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM 530.413 manufactured by Synthes Monument.
[3679805]
It was reported that during a tibial fracture procedure two monitoring system probes failed. The probes were used for 3 readings, but when the fourth reading was attempted, it came back probe failure on the display. A second probe also failed, so a new probe cable was used and still did not work. Later a third probe was tested and worked with the new cable. This is report 1 of 3 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10985101]
Device was used for diagnosis not treatment. Device is an instrument and is not implanted/explanted. Manufacturing dates; 6/9/12, 6/21/12, and 12/13/12. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records was performed and no complaint related issues were found. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2013-01876 |
| MDR Report Key | 3265661 |
| Report Source | 05,07 |
| Date Received | 2013-08-06 |
| Date of Report | 2013-07-09 |
| Date Mfgr Received | 2013-07-09 |
| Date Added to Maude | 2013-10-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | W. LINDENMUTH |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CABLE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM |
| Product Code | LXC |
| Date Received | 2013-08-06 |
| Catalog Number | 530.413 |
| Lot Number | 73400382 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1101 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-06 |