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

Catalog Number 66802002

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

Patient Problems Pain (1994); Skin Erosion (2075); Ulcer (2274); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2022

Event Type  Injury  

Event Description

It was reported that, during npwt utilizing the pico dressing was applied on the postoperative incision after stapling, but npwt was stopped because of excessive exudate on the next day, and isodine gel and a gauze were applied on the wound.One week later, erosion and ulcer were observed.Currently, the doctor continue the treatment for the erosion and ulcer with cadex and geben cream.

Manufacturer Narrative

It was reported that, during npwt utilizing the pico dressing was applied on the postoperative incision after stapling, but npwt was stopped because of excessive exudate on the next day, and isodine gel and a gauze were applied on the wound.One week later, erosion and ulcer were observed.Currently, the doctor continue the treatment for the erosion and ulcer with cadex and geben cream.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.As no lot number was provided it was not possible to carry out a device history review a complaint history review revealed no similar instances in the last 3 years in relation to this product and excessive exudate.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 review concluded that the information provided is insufficient to determine whether the patient¿s symptoms are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.It has been reported that the patient was still under treatment for the erosion and ulcer with cadex and geben cream.A thorough medical assessment cannot be rendered at this time.A probable root cause is that the wound closure was not successful, which resulted in the wound producing more exudate than expected.The device is to be used on wounds of low to moderate exudate.As the erosion and ulcer were observed after the use of isodine gel, the patient may have reacted to this which has caused the erosion and ulcer and was not a result of the use of the pico device.The 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 advice on wound suitability under section 8.1 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.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

Manufacturer Narrative

H6 has been updated.

• Brand Name: PICO 7 10CM X 20CM
• 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 ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 14366205
• MDR Text Key: 291472549
• Report Number: 8043484-2022-00169
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66802002
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female