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 Problems Skin Irritation (2076); Injury (2348)

Event Date 02/26/2020

Event Type  Injury  

Event Description

It was reported that 5 days after pico 7 application, since the postoperative period, blisters were formed in the navel area.Excessive moisture of skin was also reported although the dressing was not saturated.The dressing was removed after 5 days and the treatment was discontinued.

Manufacturer Narrative

H10.H3, h6: we have now concluded our investigation for the complaint received.The device was used for treatment.As no samples were returned, a thorough product evaluation could not be carried out.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 complaint history review was carried out using the part number provided, there have been further complaints reported with this failure mode in the past three years.A clinical investigation was carried out.It was concluded: ¿without the requested clinical information such as photos and the information regarding the type of wound being treated, a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.¿ a risk management review was carried out, which suggested some potential causes for the reported issue.The risk files for this product states multiple failure modes leading to blistering such as too much tension in the dressing border, super-absorber being too rigid and the patient moving causing tension in the dressing.The risk files also contains multiple causes of fluid pooling under the dressing such as moisture entering the super-absorber and exceeding absorbency capacity.If the super-absorbers becomes oversaturated it may become rigid causing mechanical dermatitis and also cause fluid pooling under the dressing.As stated in the ifu for this product, 'dressings should only be changed in line with standard wound management guidelines, typically every 3-4 days.At the healthcare professional¿s discretion a pico dressing may be left in place for up to 7 days.' 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 + nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + 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 HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10162349
• MDR Text Key: 195390216
• Report Number: 8043484-2020-00772
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K180698
• 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: 09/15/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention