MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-20 for SAFLEX LIFE TRACE INTRAUTERINE PRESSURE MONITOR SAFLEX IUPC 40000021 manufactured by Tyco Healthcare Kendall.
[17107619]
This intrauterine pressure catheter did not zero to air before insertion. Catheter was inserted into pt without difficulty. Intrauterine pressure catheter would not zero after insertion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029346 |
| MDR Report Key | 479813 |
| Date Received | 2003-08-20 |
| Date of Report | 2003-08-08 |
| Date of Event | 2003-06-12 |
| Date Added to Maude | 2003-08-27 |
| 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 | 0 |
| 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 | SAFLEX LIFE TRACE INTRAUTERINE PRESSURE MONITOR |
| Generic Name | INTRAUTERINE PRESSURE MONITOR |
| Product Code | HGS |
| Date Received | 2003-08-20 |
| Model Number | SAFLEX IUPC |
| Catalog Number | 40000021 |
| Lot Number | 303179 |
| ID Number | * |
| Device Expiration Date | 2006-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 468657 |
| Manufacturer | TYCO HEALTHCARE KENDALL |
| Manufacturer Address | TWO LUDLOW PARK DR CHICOPEE MA 01022 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-08-20 |