MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-06 for * OMS-T10BT manufactured by Origin Medsystems, Inc..
[21247048]
Balloon burst inside of pt. During procedure. Physician believed all the pieces were retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012241 |
| MDR Report Key | 124984 |
| Date Received | 1997-10-06 |
| Date of Report | 1997-09-26 |
| Date of Event | 1997-08-14 |
| Date Added to Maude | 1997-10-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | SURGICAL TROCAR & SYRINGE |
| Product Code | FCY |
| Date Received | 1997-10-06 |
| Model Number | * |
| Catalog Number | OMS-T10BT |
| Lot Number | 180697 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 122361 |
| Manufacturer | ORIGIN MEDSYSTEMS, INC. |
| Manufacturer Address | 135 CONSTITUTION DR. MENLO PARK CA 94025 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-10-06 |