MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-21 for INTRAUTERINE KIT WITH ISOTEC TRANSDUCER AND PREFILLED SYRING 7050005 * manufactured by Quest Medical, Inc..
[478854]
The customer reported that the set was leaking water and would not zero out. The sample was unavailable for testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2006-00052 |
| MDR Report Key | 742423 |
| Date Received | 2006-08-21 |
| Date of Report | 2006-07-21 |
| Date Mfgr Received | 2006-06-01 |
| Device Manufacturer Date | 2006-03-01 |
| 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 | INTRAUTERINE KIT WITH ISOTEC TRANSDUCER AND PREFILLED SYRING |
| Generic Name | INTRAUTERINE PRESSURE MONITOR |
| Product Code | HGS |
| Date Received | 2006-08-21 |
| Model Number | 7050005 |
| Catalog Number | * |
| Lot Number | 26219.H04 |
| ID Number | * |
| Device Expiration Date | 2009-03-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 730272 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 75002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-21 |