MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 10CM X 30CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number	66022003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on literature review "effectiveness of specific single-use incisional negative pressure wound therapy (pico system) after major lower extremity amputation", one (1) patient suffered from superficial surgical site infection (ssi) while using a pico 7 (10 x 30 cm) device after undergoing a lower extremity amputation surgery.Patient required antibiotic administration.The outcome of the patient is unknown.No further information is available.
Additional Manufacturer Narrative
Internal reference number: case-(b)(4).Takahashi h, takeda s, tanaka y, shibata r, ito h, kurahashi s, mitsuya s, murakami h.Effectiveness of specific single-use incisional negative pressure wound therapy (pico system) after major lower extremity amputation.Int j low extrem wounds.2025 mar;24(1):130-134.Doi: 10.1177/15347346231221116.Epub 2023 dec 13.Pmid: 38092691.This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

• Brand Name: PICO 7 10CM X 30CM
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 21913688
• Report Number: 8043484-2025-00026
• Device Sequence Number: 7267173
• Product Code: OMP
• UDI-Device Identifier: 05000223492182
• UDI-Public: 5000223492182
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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 Catalogue Number: 66022003
• 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: 04/22/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown