MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 15CM X 30CM; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66802007

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2020

Event Type  Injury  

Event Description

It was reported that the suction port doesn't work.It is impossible to seal.The issue was solved by adding adhesive film to maintain the seal.The device is not available for analysis.

Manufacturer Narrative

H3, h6: we have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition, it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaint history review was carried out using the lot and part numbers provided, there has been no further complaints reported with this failure mode in the past three years.The device was used for treatment.As the device was not returned, a product evaluation could not be performed.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.A clinical investigation was carried out.It was concluded; ¿without the requested clinical information 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 issue experienced.The risk files for this product contains the failure mode of user being unable to seal the dressing leading to delayed wound healing and loss of negative pressure benefits.The ifu for this product contains step-by-step instruction for application to ensure a full seal is achieved.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 15CM X 30CM
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10045575
• MDR Text Key: 190630228
• Report Number: 8043484-2020-00423
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• PMA/PMN Number: K180698
• 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: 07/24/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802007
• Device Lot Number: 201934
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 05/11/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention