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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM; OMP

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KINETIC CONCEPTS, INC. PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM; OMP Back to Search Results
Model Number WNDPPL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Necrosis (1971)
Event Date 09/27/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, the following information was provided to kci by the physician: on (b)(6) 2022, the prevena plus¿ incision management system was applied post-operatively.On (b)(6) 2022, the device was removed at the end of therapy.Upon removal, it was noted that part of the epidermis had allegedly necrotized, and the physician believed this was due to the use of the prevena plus¿ incision management system as the necrosis was only on the surface.The necrotic tissue was treated with sharp debridement and an unspecified cream.No further information provided.The prevena plus¿ incision management system was discarded; therefore, a device evaluation could not be performed.A device history record review for the prevena plus¿ incision management system lot number a01292v009 was completed.All end release testing of product and packaging met specifications.
 
Manufacturer Narrative
The prevena plus¿ incision management system was discarded; therefore, a device evaluation could not be performed.Based on the information provided, it cannot be determined that the alleged necrosis requiring debridement and application of a cream is related to the prevena plus¿ incision management system.All end release testing of product and packaging met specifications.Device labeling, available in print and online, states: the prevena plus¿ incision management system will not be effective in addressing complications associated with: ischemia to the incision or incision areas, untreated or inadequately treated infection, inadequate hemostasis of the incision, cellulitis of the incision area.The prevena plus¿ incision management 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.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.
 
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Brand Name
PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM
Type of Device
OMP
Manufacturer (Section D)
KINETIC CONCEPTS, INC.
san antonio TX 78249
Manufacturer Contact
steven jackson
6203 farinon drive
san antonio, TX 78249
2102556438
MDR Report Key15995620
MDR Text Key305605155
Report Number3009897021-2022-00180
Device Sequence Number1
Product Code OMP
UDI-Device Identifier00849554005365
UDI-Public01008495540053651724083110A01292V009
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/16/2022
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
Device Operator Health Professional
Device Model NumberWNDPPL
Device Catalogue NumberPRE4001
Device Lot NumberA01292V009
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/18/2022
Initial Date FDA Received12/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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