MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO WITH SOFT PORT 15X15CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 66801361

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that 24hours after application, a pico device stopped working.

• Brand Name: PICO WITH SOFT PORT 15X15CM
• 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: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6069154
• MDR Text Key: 59178931
• Report Number: 8043484-2016-00154
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 66801361
• Device Catalogue Number: 66801361
• Device Lot Number: 1610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2016
• 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