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

Model Number 66800951

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

Patient Problems Wound Dehiscence (1154); Skin Disorders (4543)

Event Date 08/22/2022

Event Type  Injury  

Event Description

It was reported that, on the literature review "can prophylactic incisional negative pressure wound therapy reduce wound complications after inguinal lymph node dissection for melanoma? results from a randomized controlled trial", eleven (11) patients who underwent inguinal lymph node dissection were treated with npwt using a pico 7 pump.From this cohort, one (1) patient developed a wound dehiscence with epidermolysis resulting in fewer days with the npwt device attached.Any additional measures taken to resolve this complication were not provided within the publication.The outcome of this patient is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: doi: https://doi.Org/10.1016/j.Jpra.2022.08.003.

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that, on the literature review "can prophylactic incisional negative pressure wound therapy reduce wound complications after inguinal lymph node dissection for melanoma? results from a randomized controlled trial", eleven (11) patients who underwent inguinal lymph node dissection were treated with npwt using a pico 7 pump.From this cohort, one (1) patient developed a wound dehiscence with epidermolysis resulting in fewer days with the npwt device attached.Any additional measures taken to resolve this complication were not provided within the publication.The outcome of this patient is unknown.No further information is available.The device was used for treatment and was not available for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.A lot number for the device was not provided, therefore it was not possible to carry out a device history review.A complaint history review was carried out, in relation to the pico product family.There have been no previous/further complaints reported with this, or a similar, issue in the past 3 years.A risk management review was conducted and which mitigated the reported issue with no further action or updates required.A clinical review was conducted, however, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.Due to this, and the absence of specific detail in the article relating to the root cause of the adverse event and/or the patient outcome, a conclusion could not be drawn and no further medical assessment was warranted.The matter will of course be reassessed should further medical information become available.As the specific device involved has not been identified within the complaint detail, a targeted review of labelling/product ifu cannot be carried out.A review concluded that there is not enough information to relate this event with prior escalated actions.A probable root cause for this complaint is patient skin sensitivity, in that the patient's skin was sensitive to one or more of the components of the dressing.Other possible causes are that the patient's skin was not adequately prepared prior to application, and/or the dressing was not changed frequently enough or was unsuitable for the wound type/level of exudate.This investigation is now complete with no corrective actions required.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.Corrected data: h1.

Manufacturer Narrative

H11: further assessment of the publication titled "can prophylactic incisional negative pressure wound therapy reduce wound complications after inguinal lymph node dissection for melanoma? results from a randomized controlled trial" has been performed.It is not possible to confirm a specific part number for the alleged product (pico 10x20cm), as per the smith+nephew catalog there could be more than one combination for this size of dressing.The part number under section d has been updated to unknown.Corrected data: b3 (occurrence date is unknown), d1 (brand name), d4 (catalog & udi number updated to unknown), h6 (health effect - clinical code, health effect - impact code).

• Brand Name: UNKNOWN PICO PUMP
• 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: 15535488
• MDR Text Key: 301091607
• Report Number: 8043484-2022-00187
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 66800951
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention