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

Model Number SS6

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Reaction (2414); 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

(on a port placement) appeared to have an infection and burn effect at the incision site.A two inch wide layer was placed on patient.Approx 1/3 of swiftset appeared gone postoperatively.There was a blistery red and raw pattern from where the swiftset was originally.The same pattern was present once the remaining 2/3 of the swiftset was removed.

• Brand Name: SWIFTSET
• 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: 6502936
• MDR Text Key: 73100750
• Report Number: 9617175-2017-00002
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• PMA/PMN Number: K122446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• 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: SS6
• Device Lot Number: P00203187
• Date Manufacturer Received: 01/14/2016
• Type of Device Usage: N
• Patient Sequence Number: 1