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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NASOPORE FORTE 8CM; SPLINT, INTRANASAL SEPTAL
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STRYKER INSTRUMENTS-KALAMAZOO NASOPORE FORTE 8CM; SPLINT, INTRANASAL SEPTAL Back to Search Results
Catalog Number ND02-025/08 C
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 07/17/2018
Event Type  malfunction  
Manufacturer Narrative
The device is available for return.A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported that there was a potential sterility breach on the packaging of the device.It was also reported that it was noticed prior to the procedure.It was further reported that there was no delay or adverse consequences as a result of this event.
 
Manufacturer Narrative
The reported product involved with this event was returned for evaluation.On receipt of the product the product blister pack was observed to be open.The packaging development engineer concluded that the root cause for the open pack was undetermined.A device history record (dhr) review and retained sample testing of the packaging of this lot number was performed and all manufacturing specifications were met during the time of manufacture of this product.Nasopore product ifu contains the note; "do not use if the package is open or damaged.".
 
Event Description
It was reported that there was a potential sterility breach on the packaging of the device.It was also reported that it was noticed prior to the procedure.It was further reported that there was no delay or adverse consequences as a result of this event.
 
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Brand Name
NASOPORE FORTE 8CM
Type of Device
SPLINT, INTRANASAL SEPTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7782542
MDR Text Key117144605
Report Number0001811755-2018-01582
Device Sequence Number1
Product Code LYA
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberND02-025/08 C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2018
Date Manufacturer Received10/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age1 DA
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