MAUDE Adverse Event Report: ETHICON, LLC DERMABOND PRINEO APPLICATOR; CUTANEOUS TISSUE ADHESIVE WITH MESH

Model Number PM72451B

Device Problem Stretched (1601)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2019

Event Type  malfunction  

Event Description

With attempted use of the dermabond prineo, the mesh was so tight in the device that it would stretch to the point where the product was unable to be used.Fda safety report id # (b)(4).

• Brand Name: DERMABOND PRINEO APPLICATOR
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Manufacturer (Section D): ETHICON, LLC
• MDR Report Key: 8906318
• MDR Text Key: 155017476
• Report Number: MW5089111
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: PM72451B
• Device Catalogue Number: PM72451B
• Device Lot Number: PCQ700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 01/06/1