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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO MIXEVAC III; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-PUERTO RICO MIXEVAC III; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0206015000
Device Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/04/2014
Event Type  malfunction  
Event Description
It was reported that upon opening the mixevac iii for a procedure, a slice was found in the packaging.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Event Description
It was reported that upon opening the mixevac iii for a procedure, a slice was found in the packaging.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The reported condition was not confirmed upon evaluation of the returned product.Neither the inner/outer pouch nor the tyvek paper presented any physical damage (i.E.Cut, tearing, or puncture).The inner pouch did present some scratches from the inside caused by the rubbing of the mixevac bowl or handle against the plastic bag.However, there was no perforation on the area.The device was discarded by the manufacturer.
 
Manufacturer Narrative
A follow up report will be filed after the quality investigation has been completed.
 
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Brand Name
MIXEVAC III
Type of Device
MIXER, CEMENT, FOR CLINICAL USE
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 0061 5
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 0061 5
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3777741
MDR Text Key4367195
Report Number0001811755-2014-01542
Device Sequence Number1
Product Code JDZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/04/2014
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 Number0206015000
Device Lot Number13327012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/09/2014
Initial Date FDA Received04/29/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/12/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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