MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 14 15X15CM CTN1; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802045

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); Easy Bruising (4558); Unspecified Tissue Injury (4559)

Event Date 10/15/2021

Event Type  Injury  

Event Description

A pico 14 15x15cm was reported to cause small bruising / deep tissue injury at the left edge of the wound during npwt.It is unclear if this was caused by the dressing or by not complying with position changes.Current patient health status remains unknown.

Manufacturer Narrative

Internal complaint reference case (b)(4).

Manufacturer Narrative

It was reported that during negative pressure wound therapy, small bruising/deep tissue injury occurred at the edge of the wound.It is unclear if this was caused by the dressing or by not complying with position changes.The wound was further reported to be non-serious and the patient recovered from the issue.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review on the product family revealed no similar instances in the last three years.A risk management review concluded that the sequence of events described in this complaint are not contained in the relevant risk files.There is insufficient information within the complaint description and further information included in this complaint to provide a causal link between events and the product therefore no update to the risk files is warranted.A clinical evaluation concluded that it cannot be definitively concluded that the root cause of the reported small bruising / deep tissue injury is the direct result of using the pico device as it was reported that the reported issue may have been a result of not complying with position changes.Probable root causes are incorrect application of dressings, infrequent dressing changes, or that the patient, who was being treated for a pressure ulcer did not comply with position changes.An ifu review concluded that comprehensive instructions are provided for the operation and use of the device, including advice on application and removal of dressings.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This investigation is now complete, with no corrective actions required.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.

Event Description

It was reported that during npwt with a pico 14 15x15cm, small bruising / deep tissue injury was observed at the left edge of the wound.It is unclear if this was caused by the dressing or by not complying with position changes.Current patient health status related to the adverse event is recovered since (b)(6) 2021.Patient general health has declined and is now at end of life for reasons not related to pico14 study device use.

• Brand Name: PICO 14 15X15CM 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12771357
• MDR Text Key: 280467096
• Report Number: 8043484-2021-01939
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K191760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 66802045
• Device Lot Number: 2010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2022
• Date Device Manufactured: 03/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other