ZIPSTITCH LACERATION KIT

Report

• Report Number: 3009673389-2019-00002
• Event Type: Injury
• Date Received: April 11, 2019
• Date of Event: March 10, 2019
• Report Date: March 15, 2019
• Manufacturer: ZIPLINE MEDICAL
• Product Code: OHO
• PMA / PMN Number: K170003
• Adverse Event: Yes
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE ADHESION LOSS APPEARS TO HAVE BEEN CAUSED BY THE PATIENT'S FAILURE TO FULLY CONTROL BLEEDING PRIOR TO DEVICE APPLICATION.

Description of Event or Problem · 1

FOLLOWING AN ACCIDENTAL ARM LACERATION, THE PATIENT UTILIZED THE ZIPSTITCH LACERATION KIT TO CLEAN AND DRY THE WOUND AND CLOSE IT. APPROXIMATELY 5 MINUTES AFTER APPLICATION, THE WOUND BEGAN TO BLEED, CAUSING ADHESIVE FAILURE OF THE ZIPSTITCH DEVICE. PATIENT REPORTED TO AN URGENT CARE CENTER, WHERE THE WOUND WAS CLOSED WITH SUTURES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
296415	ZIPSTITCH LACERATION KIT	FIRST AID KIT WITHOUT DRUG	OHO	ZIPLINE MEDICAL	PS2050	1834001

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention

Terms

Patient problem · 1

• Laceration(s)

Product problems · 1

• Loss of or Failure to Bond

Source type · 1

• OTHER

Type of report · 1

• Initial submission