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	Insufficient Information (4580)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In follow up with a medela clinician on 7/21/2021, the customer's daughter stated that he was currently in the hospital because his wound got infected.He received a replacement device from (b)(4), a medela distributor, one day after the display was reported not working.The daughter was not sure if the interruption in therapy was due to waiting for the new device to be delivered caused the infection.She indicated that he should be released from the hospital in another week.Medela is filing this report, which is considered a serious injury as it required medical attention.
Event or Problem Description
On (b)(6) 2021, the customer contacted (b)(4), a medela distributor, and alleged that the display on the liberty negative pressure wound therapy pump was not working correctly.(b)(4) was transferring the customer to medela when the customer hung up.

• 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: 12286603
• Report Number: 1419937-2021-00058
• Device Sequence Number: 20084102
• Product Code: OMP
• UDI-Device Identifier: 07612367015578
• UDI-Public: 7612367015578
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/06/2021
• 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