OMRIX PRESSURE REGULATOR UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-07-20 for OMRIX PRESSURE REGULATOR UNK manufactured by Omrix Biopharmaceuticals Ltd.

Event Text Entries

[17607138] This was spontaneous report from a plastic surgeon, via a company representative and concerned a female pt of unspecified age from (b)(6): (b)(4). The pt's height, weight and medical history were unspecified. The pt was treated with two kits of evicel (human clottable protein/human thrombin, solution, spray) 2 milliliters (ml) initiated on (b)(6) 2012, delivered via an morix pressure regulator to reduce post-operative bleeding (haemostasis) during abdominoplasty. Concomitant medications were not reported. The physician reported that he used evicel and the omrix pressure regulator at a distance of at least 10 centimeters. The surgeon has used evicel on several occasions before and is confident with spraying distances of at least 10 cm. At an occasion of back order for 5 ml evicel the surgeon had decided to use two small 2 ml kits of evicel and the second kit was actually more dripped than sprayed (device malfunction). Post-operative blood loss was significantly less than expected and pt was not presenting with any symptoms the day after the case. On (b)(6) 2012, the pt had multiple pulmonary emboli and was hospitalized. The pt was subsequently treated (treatment unspecified). The physician did not believe that the events were related to the suspect product and felt it was coincidence. The action taken with evicel and omrix pressure regulator was drug withdrawn. At the time of the report, the outcome of the events was unspecified. This report was serious (hospitalization) and reportable (serious injury, malfunction). This case is linked to drug/device (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003183625-2012-00661
• MDR Report Key: 2681243
• Report Source: 01,05,06
• Date Received: 2012-07-20
• Date of Report: 2012-07-11
• Date of Event: 2012-07-11
• Date Facility Aware: 2012-07-11
• Report Date: 2012-07-17
• Date Reported to FDA: 2012-07-17
• Date Mfgr Received: 2012-07-11
• Date Added to Maude: 2012-08-06
• 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: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: LICENSE #1603, MDA BLOOD BANK SHEBA HOSPITAL
• Manufacturer City: RAMAT GAN 52621
• Manufacturer Country: IS
• Manufacturer Postal: 52621
• Manufacturer Phone: 2153257722
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OMRIX PRESSURE REGULATOR
• Generic Name: OTHER
• Product Code: BXX
• Date Received: 2012-07-20
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OMRIX BIOPHARMACEUTICALS LTD
• Manufacturer Address: TEL HASHOMER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2012-07-20