MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-30 for QUIXIL (HUMAN THROMBIN, HUMAN CLOTTABLE PROTEIN) (SPRAY (NOT INHALATION)) manufactured by Omrix Biopharmaceuticals S.a..
[2850123]
This is a spontaneous serious report received from a physician via a sales rep. The pt is a female of unk age (demographics not reported) that died due to a pulmonary embolism three days following the use of quixil (fibrin sealant, human). There was no medical history or concomitant medication info provided. On (b)(6) 2011, the pt received 5 ml of quixil during a knee prosthesis surgery (batch number 0037609, serial number (b)(4)) with the pressure regulator employed at (b)(4). Three days later, the pt died from pulmonary embolism. No further info was provided at this time. The investigator considered the event not related to quixil. No causality assessment was provided in regards to the applicator/device. The company assessed the relationship of the events as unk to quixil and applicator/device. The (b)(4) was assessed as (b)(4) for both events. Further info will be requested.
Patient Sequence No: 1, Text Type: D, B5
[10172872]
The comprehensive follow-up investigation is underway. The medical assessment and the causality of the adverse events will be determined after receiving the follow-up investigation. The initial info indicates that the pressure used for intra-operative quixil delivery was above the higher limit set in the mfr instruction for use for quixil. No risk benefit assessment for cases requiring expedited submission to (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003183625-2011-00015 |
| MDR Report Key | 2689013 |
| Report Source | 05 |
| Date Received | 2011-03-30 |
| Date of Report | 2011-03-29 |
| Date of Event | 2011-03-01 |
| Date Mfgr Received | 2011-03-16 |
| Date Added to Maude | 2012-08-09 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT ZEID, US AGENT |
| Manufacturer Street | 113 SE 5TH ST |
| Manufacturer City | OAK ISLAND NC 28465 |
| Manufacturer Country | US |
| Manufacturer Postal | 28465 |
| Manufacturer Phone | 9102789176 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUIXIL (HUMAN THROMBIN, HUMAN CLOTTABLE PROTEIN) (SPRAY (NOT INHALATION)) |
| Generic Name | APPLICATOR |
| Product Code | MZM |
| Date Received | 2011-03-30 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMRIX BIOPHARMACEUTICALS S.A. |
| Manufacturer Address | 200 CHAUSSEE DE WATERLOO RHODE-ST-GENESE 1640 BE 1640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-03-30 |