MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-20 for AUTOSUTURE BDB1000 OMS PDB1000 manufactured by Dexide.
[227829]
After inflating balloon 10-12 puffs, balloon busted inside of pt during laparoscopic case. Dr able to remove balloon pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 343598 |
| MDR Report Key | 343598 |
| Date Received | 2001-07-20 |
| Date of Report | 2001-07-11 |
| Date of Event | 2001-07-11 |
| Date Facility Aware | 2001-07-11 |
| Report Date | 2001-07-18 |
| Date Added to Maude | 2001-07-27 |
| 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 | AUTOSUTURE |
| Generic Name | PREPERITONEAL DISTENTIVE BALLOON |
| Product Code | FGY |
| Date Received | 2001-07-20 |
| Returned To Mfg | 2001-07-18 |
| Model Number | BDB1000 |
| Catalog Number | OMS PDB1000 |
| Lot Number | 212030 |
| ID Number | * |
| Device Expiration Date | 2005-12-01 |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 332927 |
| Manufacturer | DEXIDE |
| Manufacturer Address | * FORT WORTH TX * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-07-20 |