MAUDE Adverse Event Report: MEDELA AG LIBERTY RENTAL PUMP WITHOUT CASE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	101037810
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service emailed the distributor and requested they send the patient a replacement device.On (b)(6) 2021, the patient was contacted by a medela clinician and he indicated the device had not been pulling the drainage as it had been before so he went to the emergency room.He additionally indicated that when a doctor in the emergency room looked at the wound he gave the him the prescription for antibiotics and the device had been removed from him for 48 hours.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).
Event or Problem Description
On (b)(6) 2021 the customer alleged to medela llc that they had gotten an infection while using the medela liberty negative pressure wound therapy pump and had gone to the doctor who prescribed antibiotics.

• Brand Name: LIBERTY RENTAL PUMP WITHOUT CASE
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug, 6341 ; SZ 6341
• MDR Report Key: 12489526
• Report Number: 1419937-2021-00081
• Device Sequence Number: 3735711
• Product Code: OMP
• UDI-Device Identifier: 07612367015578
• UDI-Public: 7612367015578
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: Lay User/Patient
• Device Model Number: 101037810
• Device Catalogue Number: 101037810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other