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

Model Number CLR222US

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

Prineo skin closure system was used during surgical case and after opening package, it appeared that the liquid adhesive had leaked out of applicator and hardened.An additional skin closure package was obtained and surgical procedure closed with any complications.

• Brand Name: DERMABOND PRINEO
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Manufacturer (Section D): ETHICON, LLC; highway 183; san lorenzo PR 00754
• MDR Report Key: 7266101
• MDR Text Key: 99908596
• Report Number: 7266101
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: (01)10705031230996
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2019
• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Device Lot Number: LJJ259
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1