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

Catalog Number UNKNOWN

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 04/12/2022

Event Type  Injury  

Event Description

It was reported that, during wound therapy applied to a knee surgery wound, an unknown pico 7 stopped working after a week.The initial surgery was performed on (b)(6) 2022 and the device stopped working on (b)(6) 2022.When the device was removed, the patient's skin came off with the tape.Subsequently, the patient had an infection whose cause is unspecified.Due to the infection, surgery was repeated.Patient's current health status is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: it was reported that, during wound therapy applied to a knee surgery wound, an unknown pico 7 stopped working after a week.The initial surgery was performed on (b)(6) 2022 and the device stopped working on (b)(6) 2022.When the device was removed, the patient's skin came off with the tape.Subsequently, the patient had an infection whose cause is unspecified.Due to the infection, surgery was repeated.Patient's current health status is unknown.No further information is available.The device was not returned for analysis.We have therefore 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 found a small number of similar instances to the reported event.There is nothing to indicate that this is outside of acceptable rates of occurrence.The clinical/medical evaluation found that there was insufficient information to determine whether the patient¿s reported loss of skin with the tape removal, together with the patient¿s experience of an (unconfirmed) infection which reportedly led to a repeated surgery, is 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.Therefore, a thorough medical assessment could not be rendered at this time.A risk management review was conducted and which mitigated the reported issue with no further action or updates required.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device, including guidance on skin preparation, application and removal of the dressing.A review concluded that there are no prior escalated actions related to this product and the reported event.The probable root causes for this complaint are one or a combination of the patient's skin not being adequately prepared prior to application of the dressing, or the dressing being incorrectly applied or removed, not in accordance with the ifu.Investigations into this matter are now complete and no further actions by smith & nephew are deemed necessary at this stage.However, 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.

• Brand Name: UNKN PICO 7
• 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: 14711296
• MDR Text Key: 294118694
• Report Number: 8043484-2022-00174
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2023
• 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): Required Intervention
• Patient Sex: Male