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

Catalog Number UNKN05004902

Device Problems Device Emits Odor (1425); Suction Problem (2170)

Patient Problem High Oxygen Saturation (2478)

Event Date 12/28/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint number: (b)(4).

Event Description

It was reported that, during a npwt a third pico 7 that was placed on (b)(6) 2023 was flashing with a green light and had no buzzing or vibrating, the dressing was sunken in, and there was a large amount of bloody brownish drainage on the dressing.The wound smells horrible.The patient does not believe the wound appearance had been affected by the pico 7 device.Patient mentioned that her oxygen pulse was reading at 88% this required patient to be using oxygen at that time.No additional information.

• 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: 18548860
• MDR Text Key: 333314452
• Report Number: 8043484-2024-00006
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNKN05004902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female