Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e3: reporter is a j&j employee.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Device report from synthes reports an event in japan as follows: it was reported that this was an unknown surgery performed on an unknown date.In the surgery, when the surgeon was tried to slide the sleeve attached to the balloon portion of the vbs trial balloon in question to the catheter side, the sleeve could not be moved because the sleeve was too tightly adhered to.Normally, the surgeon could slide the sleeve with no force at all and no resistance, but this time, he could only release the balloon about halfway by applying force.A spare product was used.No further information is available.This report is for one (1) vbs w/balloon sm.This is report 1 of 1 for complaint (b)(4).
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