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	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a nwpt, that the patient was outside smoking, noticed that the pico single use npwt 10x20cm tubing was cut off and there was a burning site.Patient is pretty sure that it didn't came from cigarette.Treatment was resumed with a back-up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H10: as no lot number was provided, a review of the device history records was not possible.A complaint history review of the amended product code, found no similar instances of the reported event.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 was reported that when the patient went out for a cigarette, the tubing was cut off and there was a burn site.Although the patient does not think this came from the cigarette, there is nothing within the device which would cause a direct burn.A cigarette from the patient or someone close to him however would be a likely cause of direct burning and would cause the issue described in the event.The probable root cause is therefore an issue caused by the device user.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.

• 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: 12321141
• Report Number: 8043484-2021-01684
• Device Sequence Number: 4980373
• Product Code: OMP
• UDI-Device Identifier: 05000223477073
• UDI-Public: 05000223477073
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 11/11/2021
• 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
• Patient Sex: Unknown