MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. NPWT PICO STERILE; PICO SINGLE USE NPWT 15 X 15CM

Model Number 66800954

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2015

Event Type  malfunction  

Event Description

The product stopped working on the third day and failed to alarm, no harm was caused.

• Brand Name: NPWT PICO STERILE
• Type of Device: PICO SINGLE USE NPWT 15 X 15CM
• 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: terry mcmahon ; 970 lake carillon dr; st petersburg 33716
• MDR Report Key: 5170942
• MDR Text Key: 29327190
• Report Number: 8043484-2015-00290
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K112127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 66800954
• Device Catalogue Number: 66800954
• Device Lot Number: 1412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 10/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR