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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SWEAT BANDS; ACCESSORY, SURGICAL APPAREL
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STRYKER INSTRUMENTS-KALAMAZOO SWEAT BANDS; ACCESSORY, SURGICAL APPAREL Back to Search Results
Catalog Number 0400205000
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Irritation (1941)
Event Date 09/23/2014
Event Type  Injury  
Event Description
It was reported that during a surgical procedure conducted at the user facility the user had a dermal allergic reaction localized to the area where the device touched the user¿s head.The procedure was completed successfully without a delay.The user sought medical advice for the allergic reaction; however, the user facility was not able to provide any further information regarding any treatment and/or medication administered as a result of this event.
 
Event Description
It was reported that during a surgical procedure conducted at the user facility the user had a dermal allergic reaction localized to the area where the device touched the user¿s head.The procedure was completed successfully without a delay.The user sought medical advice for the allergic reaction; however, the user facility was not able to provide any further information regarding any treatment and/or medication administered as a result of this event.
 
Manufacturer Narrative
The device is available for evaluation but has not yet been received.Additional information will be submitted once the device is received and the quality investigation is completed.The device has not been returned for analysis at this time.
 
Manufacturer Narrative
The reported event was not duplicated and no additional failures were confirmed.The device was tested for contamination and it was confirmed that no trace residues were present that could cause or contribute to the reported event.
 
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Brand Name
SWEAT BANDS
Type of Device
ACCESSORY, SURGICAL APPAREL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
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 Key4192507
MDR Text Key5157599
Report Number0001811755-2014-03706
Device Sequence Number1
Product Code LYU
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
Type of Report Initial,Followup
Report Date 09/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0400205000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received05/18/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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