MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-15 for PREPERITONEAL BALLOON OMSPDBS2 manufactured by Autosuture.
[20214565]
During a laparoscopic hernia repair, the preperitoneal distension balloon malfunctioned causing an injury to the pt's bladder. The balloon opened asymmetrically.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015129 |
| MDR Report Key | 1633025 |
| Date Received | 2010-03-15 |
| Date of Report | 2010-03-15 |
| Date of Event | 2010-03-08 |
| Date Added to Maude | 2010-03-19 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREPERITONEAL BALLOON |
| Generic Name | NONE |
| Product Code | GDI |
| Date Received | 2010-03-15 |
| Model Number | OMSPDBS2 |
| Lot Number | P9M0023 |
| Device Expiration Date | 2010-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AUTOSUTURE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-03-15 |