MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS F LARGE W/ SOFT PORT; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66800796

Device Problem Obstruction of Flow (2423)

Patient Problem Burn(s) (1757)

Event Date 03/25/2020

Event Type  Injury  

Event Description

It was reported that during treatment of an abdominal wound a blockage occurred in the soft port and as a consequence there was dressing saturation.Due to the drainage being interrupted, a little burn occurred over the skin, because a yellowish fluid with biliary aspect, foamy secretion and acidic ph came into contact with the skin.

• Brand Name: RENASYS F LARGE W/ SOFT PORT
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 4407940038
• MDR Report Key: 9998609
• MDR Text Key: 189580147
• Report Number: 8043484-2020-00329
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K143133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800796
• Device Lot Number: 50767371
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2021
• 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): Other; Required Intervention