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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTS_PRODUCT; TAPE AND BANDAGE, ADHESIVE
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTS_PRODUCT; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Catalog Number UNK_INS
Device Problem Biocompatibility (2886)
Patient Problems Wound Dehiscence (1154); Necrosis (1971)
Event Date 06/27/2022
Event Type  Injury  
Event Description
It was reported via medwatch mw5110915 that an infection developed around the zip device at the surgery site.User facility noted black eschar formations, wound dehiscence, and necrosis at the incision.Patient was treated with debridement and extensive wound care.
 
Manufacturer Narrative
Scrapped.
 
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Brand Name
UNKNOWN_INSTRUMENTS_PRODUCT
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
colette chung
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key15262966
MDR Text Key298278602
Report Number3009673389-2022-00005
Device Sequence Number1
Product Code KGX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_INS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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