MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 14 25X25CM CTN1; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802049

Device Problem Use of Device Problem (1670)

Patient Problem Discomfort (2330)

Event Date 03/22/2021

Event Type  Injury  

Event Description

It was reported that during use of a pico 14 25x25cm ctn1, clinical subject found the dressing uncomfortable and disturbing to sleep.However clinical subject continued the treatment with the dressing for a few more days.Then pico14 dressing was removed and previous care plan continued.The event was resolved.

Manufacturer Narrative

Information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.It was determined that this event did not lead to death or serious deterioration in the state of health of a patient, user or other person.When the malfunction was noticed, an alternate treatment was used and later a backup device was used to continue therapy, at no time was the patient without therapy and no serious injury was reported.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: PICO 14 25X25CM CTN1
• 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 Key: 11692545
• MDR Text Key: 246218949
• Report Number: 8043484-2021-00874
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: 66802049
• Device Lot Number: 2031
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention