MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-29 for BERKELEY manufactured by Cabot Medical.
[156010]
Additional info received 5/1/98: to co's knowledge, the co did not receive a report from the facility regarding this incident, either in the form of a user facility report, a letter, or a telephone call. A study was conducted to determine the pull strength of the suction ports of the device. The hook on the fixture may have interfered with the test of the distal end, yielding lower test values than would be necessary for failure in pt use. Please note that it was not stated in the user facility report if the device broke at the distal or proximal end.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 109599 |
| MDR Report Key | 109599 |
| Date Received | 1997-07-29 |
| Date of Report | 1997-07-14 |
| Date of Event | 1997-07-11 |
| Date Facility Aware | 1997-07-11 |
| Report Date | 1997-07-14 |
| Date Added to Maude | 1997-08-01 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BERKELEY |
| Generic Name | 6 MM VACURETTE F TIP |
| Product Code | HHK |
| Date Received | 1997-07-29 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 7M 1051 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 107726 |
| Manufacturer | CABOT MEDICAL |
| Manufacturer Address | 2021 CABOT BLVD WEST LANGHORNE PA 19047 US |
| Baseline Brand Name | BERKELEY VACURETTE CANNULA, F-TIP |
| Baseline Generic Name | FLEXIBLE TIP CURETTE |
| Baseline Model No | NA |
| Baseline Catalog No | 21665 |
| Baseline ID | F-TIP VACURETTE |
| Baseline Device Family | F-TIP VACURETTE |
| 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 | 1. Required No Informationntervention | 1997-07-29 |