MAUDE Adverse Event Report: PREVENA¿ 125 THERAPY UNIT; OMP

Model Number WNDPRV

Device Problem Insufficient Information (3190)

Patient Problem Seroma (2069)

Event Date 07/06/2018

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2018, the following information was reported to kci: the hospital could not provide the prevena¿ 125 therapy unit lot number therefore a device history review could not be performed.Based on the information provided, it cannot be determined that the alleged seroma is related to the prevena¿ 125 therapy unit.Prevena¿ 125 therapy system should be used with caution in the following patients: patients with fragile skin surrounding the incision as they may experience skin or tissue damage upon removal of the prevena dressing.Dressing components: to avoid trauma to the skin, do not pull or stretch the adhesive border of the dressing during application.Dressing application instructions: caution: if the dressing covers the umbilicus, the umbilicus must first be fully filled with an anti-microbial petroleum gauze prior to dressing application.

Event Description

On 08 jul 2018, the following information was reported to kci by the hospital: on (b)(6) 2018, a post operative cesarean section patient using the prevena¿ 125 therapy unit with prevena¿ peel and place¿ dressing kit allegedly developed seroma.The patient was sent to the emergency room and underwent an incision and drainage.No additional information is available.The prevena¿ 125 therapy unit lot number was not provided, therefore a device history review could not be performed.

• Brand Name: PREVENA¿ 125 THERAPY UNIT
• Type of Device: OMP
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 7742712
• MDR Text Key: 115805033
• Report Number: 3009897021-2018-00072
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K100821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDPRV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention