MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTS_PRODUCT; TAPE AND BANDAGE, ADHESIVE

Catalog Number UNK_INS

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Wound Dehiscence (1154); Hemorrhage/Bleeding (1888)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

Device scrapped.

Event Description

The user facility reported that an unknown zip device lost adhesion and patient returned to have wound closed.Patient had blood loss.Attempts are being made to gather further information about the treatment.

Manufacturer Narrative

H3 other text : device scrapped.

Event Description

The user facility reported that an unknown zip device lost adhesion and patient returned to have wound closed.The user facility cut off the bottom section of the zip from the patient and removed it.Zip lost adhesive ability on the wound.Patient had blood loss.This patient also required skin clips applied at the bottom of their wound.

• 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 Key: 16832226
• MDR Text Key: 314181291
• Report Number: 3015967359-2023-01055
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2023
• 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 Number: 1
• Patient Outcome(s): Required Intervention