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

Model Number	101037810/16283M
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A medela clinician gave the nurse instructions on wound preparation and dressing set up to avoid possible allergic reaction to acrylic in film.The clinician gave the nurse instructions to call back with an update if the allergic reaction did not resolve.On 9/13/2021, a medela clinician followed up with the director of wound care at the hospital to get additional information on the patient.The director stated that the patient received claritin and solumedrol and it helped treat the reaction.The patient was not placed back on the device.Medela is filing this report, which is considered a serious injury as it required medical attention.
Event or Problem Description
On 08/30/2021, the nurse at (b)(6) hospital contacted medela llc and alleged that the patient had a possible allergic reaction from the film at four wound sites while using the liberty negative pressure wound therapy pump.

• 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: 12487811
• Report Number: 1419937-2021-00080
• Device Sequence Number: 17077582
• 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: Nurse
• 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: Health Professional
• Device Model Number: 101037810/16283M
• Device Catalogue Number: 101037810/16283M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• 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