Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 15CM X 30CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW MEDICAL LTD. PICO 7 15CM X 30CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP Back to Search Results
Catalog Number 66802007
Device Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  malfunction  
Event Description
It was reported that, during a thr, four lamps of one (1) pico 7 15cm x 30cm shone and then the pump stopped working.This happened before use in patient (during set up).Treatment was performed, after a non-significant delay, with a back-up device.Patient was not injured as consequence of this problem.
 
Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.The loss of negative pressure wound therapy due to an inoperative or 'stopped' pump will not directly cause or contribute to serious injury or death as the pico dressing can revert to managing the wound as a standard multilayer dressing.No risk to patient safety is anticipated.This event is considered not reportable pursuant to 21 cfr part 803.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PICO 7 15CM X 30CM
Type of Device
NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK  HU3 2BN
MDR Report Key12096005
MDR Text Key259366281
Report Number8043484-2021-01620
Device Sequence Number1
Product Code OMP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66802007
Device Lot Number2040
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-