MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-07-21 for ISOFLO INTRAUTERINE PRESSURE MONITORING AMNIOINFUSION SET 7052005G * manufactured by Quest Medical, Inc..
[18912785]
The customer reported for a doctor that he had to use three of our iupcs to get one that worked. No further details are available at this time. It is unk if the samples were saved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2006-00061 |
| MDR Report Key | 742465 |
| Report Source | 05,06 |
| Date Received | 2006-07-21 |
| Date of Report | 2006-07-21 |
| Date Mfgr Received | 2006-06-29 |
| Date Added to Maude | 2006-08-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MEGAN SIMS |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723909800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOFLO INTRAUTERINE PRESSURE MONITORING AMNIOINFUSION SET |
| Generic Name | INTRAUTERINE PRESSURE MONITOR |
| Product Code | HGS |
| Date Received | 2006-07-21 |
| Model Number | 7052005G |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 730312 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 75002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-21 |