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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH CONFIDENCE KIT, NO NEEDLES; CEMENT, BONE, VERTEBROPLASTY

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MEDOS INTERNATIONAL SàRL CH CONFIDENCE KIT, NO NEEDLES; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 283913000
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
During cement injection the cement pump built pressure until the upper gasket was broken and leaked.Was surgery delayed due to the reported event? no.Action taken when event occurred? replacing the cement pump to a new one.Was procedure successfully completed? yes.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences: no.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no.Is the patient part of a clinical study: unknown.Ip (b)(4).Device property of: none.Device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.This complaint involves two (2) devices.
 
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Brand Name
CONFIDENCE KIT, NO NEEDLES
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
Manufacturer (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle
SZ  
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9263307
MDR Text Key179790330
Report Number1526439-2019-52350
Device Sequence Number1
Product Code NDN
UDI-Device Identifier10705034209630
UDI-Public10705034209630
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K060300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number283913000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/10/2019
Initial Date FDA Received10/31/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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