MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-20 for KAHN UTERINE CANNULA GL2360 manufactured by Allegiance Healthcare Corporation.
[297894]
Dr. States that she was performing procedure when the tip of the device broke off into the uterus. The patient was taken to the or and had the device surgically removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2002-00163 |
| MDR Report Key | 433697 |
| Date Received | 2002-12-20 |
| Date of Report | 2002-12-20 |
| Date of Event | 2002-11-20 |
| Date Mfgr Received | 2002-11-25 |
| Date Added to Maude | 2002-12-23 |
| 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 | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KAHN UTERINE CANNULA |
| Generic Name | INSTRUMENT |
| Product Code | HGH |
| Date Received | 2002-12-20 |
| Model Number | GL2360 |
| Catalog Number | GL2360 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 422638 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORPORATION |
| Manufacturer Address | 1430 WAUKEGAN ROAD MCGAW PARK IL 60085 US |
| Baseline Brand Name | KAHN UTERINE CANNULA |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | GL2360 |
| Baseline Catalog No | GL2360 |
| Baseline ID | NA |
| Baseline Device Family | INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-12-20 |