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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH HIGH FLOW TIP; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH HIGH FLOW TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210114000
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 08/26/2015
Event Type  malfunction  
Manufacturer Narrative
Failure analysis is in progress.
 
Event Description
It was reported that at the user facility foreign material was found in the sterile packaging of the product.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The product was scrapped by stryker.
 
Event Description
It was reported that at the user facility foreign material was found in the sterile packaging of the product.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
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Brand Name
INTERPULSE HANDPIECE WITH HIGH FLOW TIP
Type of Device
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5092315
MDR Text Key26358946
Report Number0001811755-2015-03484
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Followup
Report Date 08/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number0210114000
Device Lot Number15114032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received10/21/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2015
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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