MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-03-19 for DSB DETACHABLE SILICONE BALLOON * TBD manufactured by Target Therapeutics/a Division Of Boston Scientific Corporation.
[254531]
It was reported to bsc/target that during the procedure the dsb detachable silicone balloon detached prematurely. The condition of the patient is unknown. Company representative will follow-up with additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000078-2002-00019 |
| MDR Report Key | 384130 |
| Report Source | 07 |
| Date Received | 2002-03-19 |
| Date of Report | 2002-03-18 |
| Date of Event | 2002-02-13 |
| Date Mfgr Received | 2002-02-18 |
| Date Added to Maude | 2002-03-26 |
| 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 | ANITA NEUMAN |
| Manufacturer Street | 47900 BAYSIDE PARKWAY |
| Manufacturer City | FREMONT CA 945386515 |
| Manufacturer Country | US |
| Manufacturer Postal | 945386515 |
| Manufacturer Phone | 8006622415 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DSB DETACHABLE SILICONE BALLOON |
| Generic Name | DETACHABLE BALLOON |
| Product Code | MZQ |
| Date Received | 2002-03-19 |
| Model Number | * |
| Catalog Number | TBD |
| Lot Number | TBD |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 373177 |
| Manufacturer | TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 47900 BAYSIDE PARKWAY FREMONT CA 945386515 US |
| Baseline Brand Name | DSB DETACHABLE SILICONE BALLOON |
| Baseline Generic Name | DETACHABLE BALLOON |
| Baseline Model No | * |
| Baseline Catalog No | TBD |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-03-19 |