Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ZIP 24 SURGICAL SKIN CLOSURE DEVICE; TAPE AND BANDAGE, ADHESIVE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ZIP 24 SURGICAL SKIN CLOSURE DEVICE; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Catalog Number PS1240
Medical Device Problem Code Biocompatibility (2886)
Health Effect - Clinical Codes Bacterial Infection (1735); Fever (1858); Blister (4537)
Date of Event 07/14/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device discarded.
 
Event or Problem Description
The user facility reported that the patient had a blister reaction from the zip device upon removal post procedure.Patient had pain and burning with the reaction.Patient was treated with a prescription antibiotics and topical ointment to treat cellulitis and prevent infection.Patient also had a fever.Patient was healing well since the last follow up visit.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ZIP 24 SURGICAL SKIN CLOSURE DEVICE
Common Device Name
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12309339
Report Number3015967359-2021-01791
Device Sequence Number3164646
Product Code KGX
UDI-Device Identifier10865379000030
UDI-Public10865379000030
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue NumberPS1240
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/14/2021
Initial Report FDA Received Date08/11/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age65 YR
-
-