MAUDE Adverse Event Report: SMITH AND NEPHEW MEDICAL LTD. PICO DRESSING; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

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

Patient Problems High Blood Pressure/ Hypertension (1908); Seroma (2069); Low Oxygen Saturation (2477)

Event Date 07/22/2018

Event Type  malfunction  

Event Description

The patient was discharged from mother baby.At that time, her incision had seroma behind it that was leaking and required a pico dressing.When the patient returned to visit her newborn in the neo-natal icu, she noticed that her pico dressing had become completely saturated and the battery pack had become disconnected from the dressing.The patient went immediately to the obstetrics emergency department.Physician performed a "wound exploration" and applied a new pico dressing.The patient was given a spare pico dressing set to have on hand in case the current dressing needed replacing prior to her obgyn removing it in 10 days.The patient was to be an outpatient, however, she was unable to maintain her o2 saturation without at least 4l/nc of o2.On admit to mother baby as an observation patient, she required 10l of o2 to maintain an oxygen saturation of > 94%.The patient also had ongoing hypertension.The patient did report that she had recently quit smoking prior to this admission and had not continued to use the incentive spirometer after discharge.

• Brand Name: PICO DRESSING
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH AND NEPHEW MEDICAL LTD.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 7888791
• MDR Text Key: 120715528
• Report Number: 7888791
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/05/2018,08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9125 DA