MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 10CM X 20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66800951
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after npwt utilizing a pico single use npwt 10x20cm, the patient had to go for further amputation/operation, and is blaming the nurse and the device.The current health status of the patient is unknown.
Additional Manufacturer Narrative
Additional information: h3, h6.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.It is not possible to determine if the device contributed to the event.It was reported that the after npwt the patient had to go for further amputation.There is no further information available.As no lot number was provided, it was not possible to carry out a device history review a complaint history review of the product family revealed no similar instances in the last three years.A clinical assessment determined that without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.A risk management review concluded that there was insufficient information to provide a link between events and the product so no update to the risk files is necessary at this time.Probable root cause may relate to incorrect application of the dressings or unsuitability of the wound.The instructions for use provides details about the type of wounds the device can be used on, guidance on wound suitability and contraindications which warn against use under certain circumstances.Users of the reported product are advised to consult the ifu to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including application and removal of dressings and skin preparation prior to use.This investigation is now complete, with no corrective actions required at this time.However, we will continue to monitor for any adverse trends relating to this product range.Corrected information: b5, d1, d4.
Event or Problem Description
It was reported that, after npwt utilizing a pico 7 10cm x 20cm, the patient had to undergo further amputation/operation, and is blaming the nurse and the device.The current health status of the patient is unknown.

• Brand Name: PICO 7 10CM X 20CM
• Common Device Name: 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: 12831801
• Report Number: 8043484-2021-01963
• Device Sequence Number: 11904921
• Product Code: OMP
• UDI-Device Identifier: 05000223493929
• UDI-Public: 05000223493929
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: 66800951
• Device Catalogue Number: 66802002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown