PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM
Report
- Report Number
- 3009897021-2019-00089
- Event Type
- Injury
- Date Received
- July 19, 2019
- Date of Event
- October 1, 2018
- Report Date
- August 9, 2019
- Manufacturer
- KINETIC CONCEPTS, INC.
- Product Code
- OMP
- PMA / PMN Number
- K153199
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 117
Narratives
SENT ON (B)(6) 2019: SECTION B5 STATED, "ON (B)(6) 2019, THE... BY THE PREVENA¿ INCISION MANAGEMENT SYSTEM." CORRECTION: "ON (B)(6) 2019, THE...BY THE PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM." SECTION D1 STATED, "PREVENA¿ INCISION MANAGEMENT SYSTEM" CORRECTION: "PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM" SECTION D4 STATED, "WNDPRV" CORRECTION "WNDPPL" SECTION G5 STATED, "K100821" CORRECTION "K153199" SECTION H10 STATED, "BASED ON THE INFORMATION. TO THE PREVENA¿ INCISION MANAGEMENT SYSTEM." CORRECTION: "BASED ON THE INFORMATION.TO THE PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM." BASED ON THE DEVICE CORRECTION AND NO ADDITIONAL INFORMATION PROVIDED, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION IS RELATED TO PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL CLINICAL INFORMATION.
ON (B)(6) 2019, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE PRACTITIONER WITH PHOTOS OF THE WOUND: THE PATIENT ALLEGED THIRD DEGREE BURNS WERE INCURRED BY THE PREVENA PLUS ¿ INCISION MANAGEMENT SYSTEM IN (B)(6) 2018. ON (B)(6) 2019, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY NURSE PRACTITIONER: THE PATIENT WAS USING A PREVENA PLUS¿ CUSTOMIZABLE DRESSING. NO ADDITIONAL INFORMATION AVAILABLE. THE PREVENA PLUS¿ CUSTOMIZABLE DRESSING IDENTIFIER HAS NOT BEEN PROVIDED, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.
DATE OF EVENT: SPECIFIC DATE OF THE EVENT IS UNKNOWN AS THE PATIENT STATED THE OCCURRENCE WAS FROM (B)(6) 2018. THE SPECIFIC DATE WAS NOT PROVIDED. DEVICE EVALUATED BY MFR: DEVICE IDENTIFIERS HAVE NOT BEEN PROVIDED AND THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED BLISTERING RESULTING IN AN INFECTION IS RELATED TO THE PREVENA¿ INCISION MANAGEMENT SYSTEM. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WARNINGS: INFECTION: THE FOLLOWING SYMPTOMS MAY MEAN THAT YOUR INCISION IS INFECTED. CALL YOUR DOCTOR RIGHT AWAY IF YOU: HAVE SWELLING AT THE DRESSING; FEEL FEVERISH; HAVE PUS AT THE DRESSING SITE; FEEL AN INCREASE IN SORENESS AT THE DRESSING; HAVE REDNESS AROUND THE DRESSING; FEEL ITCHING AT THE DRESSING; FEEL WARMTH AT THE DRESSING; HAVE A BAD ODOR AT THE DRESSING.
ON 19-JUN-2019, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE PRACTITIONER WITH PHOTOS OF THE WOUND: THE PATIENT ALLEGED THIRD DEGREE BURNS WERE INCURRED BY THE PREVENA ¿ INCISION MANAGEMENT SYSTEM IN (B)(6) 2018. ON 20-JUN-2019, KCI REVIEWED THE IMAGES PROVIDED WHICH EXHIBITED A SUTURED WOUND THAT HAS TWO AREAS THAT HAVE THE EPIDERMAL LAYER OF THE SKIN REMOVED. ONE OF THE AREAS APPEARS TO HAVE SLOUGH AND BLISTERING IS OBSERVED. REDNESS AND SWELLING ARE OBSERVED IN SOME AREAS OF THE PERIWOUND AND ON THE INCISION LINE. ON 11-JUL-2019, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE PRACTITIONER: THE PATIENT INCURRED BLISTERS WHICH ALLEGEDLY RESULTED IN A STAPHYLOCOCCUS INFECTION THAT REQUIRED ANTIBIOTIC THERAPY. NO FURTHER INFORMATION IS AVAILABLE. THE DEVICE IDENTIFIERS HAVE NOT BEEN PROVIDED AND THE PRODUCT WAS NOT RETURNED, THEREFORE A DEVICE EVALUATION AND A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601431 | PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM | OMP | OMP | KINETIC CONCEPTS, INC. | WNDPPL | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |