MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 10CM X 30CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 02/11/2020

Event Type  Injury  

Event Description

It was reported that the customer says that the pico dressing did not absorb the exudate despite being perfectly sealed and without leakage alarms.The dressing was not saturated but the exudate accumulated between the skin and the silicone interface expanding laterally without being absorbed.This resulted in skin maceration.In this case, this episode had no consequences for the patient.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A complaints history review was carried out using the part number provided, there have been no further complaints reported with this failure mode in the past three years.The device was used for treatment.It was reported that the dressing did not absorb exudate although it was sealed sufficiently and the leak indicator light was not illuminated.No samples were returned for evaluation.A clinical assessment was carried out.It was concluded: ¿three pictures were provided.The picture of the wound does not appear to be macerated at that time.No other clinical/ medical documentation was provided to investigate this issue.All documents and images provided as of this date have been reviewed and unless noted do not contribute to the clinical investigation.Without supporting clinical/ medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.In conclusion, the root cause of the reported maceration cannot be concluded and is not obvious in the provided pictures.It is unknown if the dressing itself was an inappropriate choice for the wound.¿ a risk management review was carried out.The risk files for this product lists multiple assembly failures that can lead to impaired product performance.This has the potential failure effect of skin maceration.The risk files also outline that if the dressing is applied to a wound with either too high a volume or exudate rate or is not changed regularly enough, it can lead to maceration.Without more information, the failure mode cannot be narrowed down any further.As stated in the ifu for this product, ¿the pico 7 dual dressing kit is intended to be used for up to 7 days on low to moderately exuding wounds.¿ we have not been able to confirm a relationship between the event and the device or identify a definitive root cause.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: PICO 7 10CM X 30CM
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 9732603
• MDR Text Key: 180843719
• Report Number: 8043484-2020-00119
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K172005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66802003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other