MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ZIP 24 SURGICAL SKIN CLOSURE DEVICE; TAPE AND BANDAGE, ADHESIVE

Catalog Number PS1240

Device Problem Biocompatibility (2886)

Patient Problems Bacterial Infection (1735); Fever (1858); Blister (4537)

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

Device discarded.

Event 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.

• Brand Name: ZIP 24 SURGICAL SKIN CLOSURE DEVICE
• 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: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 12309339
• MDR Text Key: 266078317
• Report Number: 3015967359-2021-01791
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 10865379000030
• UDI-Public: 10865379000030
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PS1240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR