MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1998-11-23 for PDB1 OMS-PDB1000 04572 manufactured by Origin Medsystems, Inc..
[143373]
During a laparoscopic hernia repair, a bladder tear was noticed. A balloon had been inserted into a pt, after a certain period of time, the balloon popped. The unit was removed and second unit was inserted. At this point, a bladder tear was noticed. A urologist was then called in to repair the baldder neck tear. The procedure was aborted to allow time for the pt to recover. The pt was last reported in good condition. No other complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939738-1998-00024 |
| MDR Report Key | 198672 |
| Report Source | 05,06,07 |
| Date Received | 1998-11-23 |
| Date of Report | 1998-10-21 |
| Report Date | 1998-10-21 |
| Date Reported to Mfgr | 1998-10-21 |
| Date Mfgr Received | 1998-10-21 |
| Device Manufacturer Date | 1998-07-01 |
| Date Added to Maude | 1998-11-27 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PDB1 |
| Generic Name | PREPERITONEAL DISTENTION BALLOON |
| Product Code | FGY |
| Date Received | 1998-11-23 |
| Model Number | OMS-PDB1000 |
| Catalog Number | 04572 |
| Lot Number | 0707981 |
| ID Number | * |
| Device Expiration Date | 2000-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 192998 |
| Manufacturer | ORIGIN MEDSYSTEMS, INC. |
| Manufacturer Address | 135 CONSTITUTION DR. MENLO PARK CA 94025 US |
| Baseline Brand Name | PREPERITONEAL DISTENTION BALLOON |
| Baseline Generic Name | DISTENTION BALLOON |
| Baseline Model No | OMS-PDB1000 |
| Baseline Catalog No | OMS-PDB1000 |
| Baseline ID | NA |
| Baseline Device Family | PREPERITONEAL DISTENTION BALLOON |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K935426 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 1998-11-23 |