MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO SINGLE USE NPWT 10 X 30CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66800952

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problems Purulent Discharge (1812); No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2017

Event Type  malfunction  

Event Description

The pico had been in use for 5 days.(it was first applied on the (b)(6)).The dressing should have been changed over the weekend as the dressings was sodden and hanging off.The green light to indicate that the machine was working was flashing.As the dressing was not fully adhered it should have been flashing to show that there was a leak however it was not.

Manufacturer Narrative

(b)(4).

• Brand Name: PICO SINGLE USE NPWT 10 X 30CM
• 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: markus poettker ; scachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6735433
• MDR Text Key: 80919487
• Report Number: 8043484-2017-00181
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K163387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 66800952
• Device Lot Number: 1704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/04/2017
• Was Device Evaluated by Manufacturer?: No
• 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