MAUDE Adverse Event Report: ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED LIQUIBAND EXCEED; TOPICAL SKIN ADHESIVE

Model Number LX6

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Investigation was performed on retain samples, no abnormalities were noted.At this time we are unable to confirm if the device caused or contributed to a serious injury.If further information becomes available a follow-up report will be submitted.

Event Description

We had 2 cases last week where liquiband exceed came off after 1 day.The incisions had partial dehiscence and infection.

• Brand Name: LIQUIBAND EXCEED
• Type of Device: TOPICAL SKIN ADHESIVE
• Manufacturer (Section D): ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED; western wood way; plymouth, PL75B G; UK PL75BG
• Manufacturer Contact: western wood way; plymouth, PL75B-G ; 752209955
• MDR Report Key: 6502934
• MDR Text Key: 73100306
• Report Number: 9617175-2017-00003
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• PMA/PMN Number: K151182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: LX6
• Device Lot Number: P00203686
• Date Manufacturer Received: 02/05/2016
• Type of Device Usage: N
• Patient Sequence Number: 1