INVIA MOTION+ ENDURE SINGLE

Report

Report Number: 1419937-2020-00020
Event Type: Injury
Date Received: March 6, 2020
Date of Event: February 5, 2020
Manufacturer: MEDELA AG
Product Code: OMP
PMA / PMN Number: K142626
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

MEDELA LLC FOLLOWED-UP WITH CLINICIANS AT THE HEALTHCARE FACILITY. THE RESULTS OF THOSE INTERVIEWS INDICATE NORMAL WOUND DRAINAGE AND NO SIGNS OF SWELLING, REDNESS OR ADVERSE REACTION UPON REMOVAL OF THE MEDELA DEVICE. THE PRODUCT INFORMATION WAS REVIEWED AND THE CONTACT MATERIAL (FOAM AND TRANSPARENT FILM) WAS REVIEWED DURING THE DESIGN PROCESS FOR CYTOTOXICITY AND SENSITIVITY PER ISO10993-5 AND ISO10993-10, RESPECTIVELY, AND WAS DETERMINED TO HAVE MET ALL REQUIREMENTS. ADDITIONALLY, WHEN REVIEWING THE LOT INFORMATION FOR THE DRESSING SET, IT WAS DETERMINED THAT THERE WERE NO DEVIATIONS, STERILITY WAS PROVEN, AND LAL TESTING WAS COMPLETED WITH PRODUCT MEETING THE REQUIREMENTS FOR IMPLANTABLE DEVICES. THE MOTION ENDURE NEGATIVE PRESSURE WOUND THERAPY DEVICE WAS DESIGNED AND MANUFACTURED MEETING ALL SPECIFICATIONS.

Description of Event or Problem · 1

ON (B)(6) 2020, A DISTRIBUTOR REPRESENTATIVE REPORTED TO MEDELA LLC THAT A NEGATIVE PRESSURE WOUND THERAPY DEVICE WAS PLACED ON PATIENT ON (B)(6) 2020 AND APPROXIMATELY 15-20 MINUTES AFTER PLACEMENT, THE PATIENT EXPRESSED COMPLAINTS RELATED TO PAIN (6 OUT OF 10), REDNESS AND SWELLING. ADDITIONALLY, THE PATIENT DISPLAYED SIGNS OF INCREASED ANXIETY. THE HEALTHCARE FACILITY CASE MANAGER REPORTED TO THE DISTRIBUTOR REPRESENTATIVE THAT THE PATIENT HAD A REACTION AFTER THE NEGATIVE PRESSURE WOUND THERAPY DEVICE WAS PLACED ON THE WOUND.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
265394	INVIA MOTION+ ENDURE SINGLE	NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP	OMP	MEDELA AG	0874010	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other