ORIGIN * OMS-PDBS2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-28 for ORIGIN * OMS-PDBS2 manufactured by Origin Medsystems, Inc..

Event Text Entries

[20923956] Origin balloon when opened noted to have holes in blue wrapper and outer package.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017995
• MDR Report Key: 260427
• Date Received: 2000-01-28
• Date of Report: 2000-01-27
• Date of Event: 2000-01-13
• Date Added to Maude: 2000-02-02
• 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: PHYSICIAN ASSISTANT
• 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

Device Sequence Number: 1

• Brand Name: ORIGIN
• Generic Name: ORIGIN BALLOON PREPERITONEAL BALLOON
• Product Code: FGY
• Date Received: 2000-01-28
• Returned To Mfg: 2000-01-27
• Model Number: *
• Catalog Number: OMS-PDBS2
• Lot Number: Z809981
• ID Number: *
• Device Expiration Date: 2000-09-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 252229
• 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-PDBS2
• Baseline Catalog No: OMS-PDBS2
• Baseline ID: *
• Baseline Device Family: DISTENTION BALLOON
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 24
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K922094
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Device Sequence Number: 2

• Brand Name: ORIGIN
• Generic Name: ORIGIN BALLOON (PREPERITONEAL BALLOON)
• Product Code: FGY
• Date Received: 2000-01-28
• Returned To Mfg: 2000-01-27
• Model Number: *
• Catalog Number: OMS-PDBS2
• Lot Number: 2501991
• ID Number: *
• Device Expiration Date: 2001-01-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 252231
• 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-PDBS2
• Baseline Catalog No: OMS-PDBS2
• Baseline ID: *
• Baseline Device Family: DISTENTION BALLOON
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 24
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K922094
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2000-01-28