OASIS ULTRA N/A TRI-LAYER MATRIX
Report
- Report Number
- 1835959-2014-00974
- Event Type
- Injury
- Date Received
- November 7, 2014
- Date of Event
- May 7, 2014
- Report Date
- May 12, 2016
- Manufacturer
- COOK BIOTECH
- Product Code
- KGN
- PMA / PMN Number
- K061711
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION INTO THIS FEEDBACK INCLUDED A REVIEW OF THE FEEDBACK DETAILS AND A REVIEW OF THE IFU. THE PATIENT DID NOT PROVIDE HER PHYSICIAN'S NAME; SHE WAS OPPOSED TO (B)(4) FOLLOW-UP WITH HER PHYSICIAN FOR THE PURPOSE OF GATHERING ADDITIONAL CASE SPECIFIC DETAILS. SUMMARY OF INVESTIGATION FINDINGS: THE ROOT CAUSE OF THE PATIENT'S COURSE OF ONGOING EVENTS IS NOT BELIEVED TO BE DIRECTLY RELATED TO THE USE OF THE OASIS ULTRA TRI-LAYER MATRIX. THE PATIENT INDICATED SHE HAD AN INFECTED WOUND AT THE TIME OF APPLICATION OF THE OASIS AS THE RESULT OF HER INSECT BITE AND THAT SHE REMOVED THE OASIS THREE DAYS AFTER IT WAS APPLIED, INFECTION, ULCERATION, NECROSIS, WOUND EXUDATE, ODOR, AND NEED FOR HOSPITALIZATION AND DEBRIDEMENT CAN BE A TYPICAL COURSE OF EVENTS OF A WOUND ORIGINATING FROM AN INSECT BITE. ALTHOUGH THE LOT NUMBER OF THE PRODUCT USED WAS NOT PROVIDED BY THE PATIENT, COOK BIOTECH INCORPORATED HAS A VALIDATED STERILIZATION PROCESS WITH A STERILITY ASSURANCE LEVEL (SAL) OF 10 TO THE POWER OF 6. THE ORGANISM, PSEUDOMONAS SP., IS NOT KNOWN TO BE RESISTANT TO ETHYLENE OXIDE GAS, WHICH CBI USES AS A STERILANT. THEREFORE, THE PSEUDOMONAS SP. INFECTION IS NOT ATTRIBUTED TO THE DEVICE. SEE SCANNED PAGE.
DEVICE COMMON NAME IS ANIMAL-DERIVED, EXTRACELLULAR MATRIX WOUND CARE PRODUCT; PRODUCT CODE IS KGN. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED. PRODUCT CATALOG NUMBER UNKNOWN, PRODUCT UNSPECIFIED. SURGEON NAME NOT PROVIDED BY THE COMPLAINANT. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN. DEVICE COMMON NAME IS ANIMAL-DERIVED, EXTRACELLULAR MATRIX WOUND CARE PRODUCT; PRODUCT CODE IS KGN. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED. PRODUCT CATALOG NUMBER UNKNOWN, PRODUCT UNSPECIFIED. SURGEON NAME NOT PROVIDED BY THE COMPLAINANT. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN.
(B)(4). THE ROOT CAUSE OF THE PATIENT'S COURSE OF ONGOING EVENTS IS NOT BELIEVED TO BE DIRECTLY RELATED TO THE USE OF THE OASIS ULTRA TRI-LAYER MATRIX. THE PATIENT INDICATED SHE HAD AN INFECTED WOUND AT THE TIME OF APPLICATION OF THE OASIS AS THE RESULT OF AN INSECT BITE AND THAT SHE REMOVED THE OASIS THREE DAYS AFTER IT WAS APPLIED. INFECTION, ULCERATION, NECROSIS, WOUND EXUDATE, ODOR, AND NEED FOR HOSPITALIZATION AND DEBRIDEMENT CAN BE A TYPICAL COURSE OF EVENTS OF A WOUND ORIGINATING FROM AN INSECT BITE. IN REGARDS TO IFU STATEMENTS REGARDING THE USE OF THE PRODUCT ON AN INFECTED WOUND, THE IFU STATES "OASIS ULTRA TRI-LAYER MATRIX SHOULD NOT BE APPLIED UNTIL EXCESSIVE EXUDATE, BLEEDING, ACUTE SWELLING, AND INFECTION IS CONTROLLED." THE OBSERVATION OF THE WOUND AND THE DECISION AS TO WHETHER THE PRODUCT SHOULD BE APPLIED TO THE WOUND IS UP TO THE PHYSICIAN'S DISCRETION AND TRAINED MEDICAL JUDGMENT. THE COMPLICATIONS NOTED IN THE IFU INCLUDE "INFECTION, CHRONIC INFLAMMATION (INITIAL APPLICATION OF WOUND DRESSINGS MAY BE ASSOCIATED WITH TRANSIENT, MILD, LOCALIZED INFLAMMATION), ALLERGIC REACTIONS, AND EXCESSIVE REDNESS, PAIN, SWELLING, OR BLISTERING." ALTHOUGH THE LOT NUMBER OF THE PRODUCT USED WAS NOT PROVIDED BY THE PATIENT, COOK BIOTECH INCORPORATED HAS A VALIDATED STERILIZATION PROCESS WITH A STERILITY ASSURANCE LEVEL (SAL) OF 10^-6. THE ORGANISM, PSEUDOMONAS SP., IS NOT KNOWN TO BE RESISTANT TO ETHYLENE OXIDE GAS, WHICH CBI USES AS A STERILANT. THEREFORE, THE PSEUDOMONAS SP. INFECTION IS NOT ATTRIBUTED TO THE DEVICE. UPDATE: THE PREVIOUS INVESTIGATION SUMMARY AND ROOT CAUSE ANALYSIS ARE STILL RELEVANT. THE ONE APPLICATION OF OASIS IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S ORIGINAL SYMPTOMS / COMPLICATIONS NOR THE ONGOING SYMPTOMS / COMPLICATIONS THAT SHE REPORTED. UPDATE #2: THE PREVIOUS INVESTIGATION SUMMARY AND ROOT CAUSE ANALYSIS ARE STILL RELEVANT. THE ONE APPLICATION OF OASIS IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S ORIGINAL SYMPTOMS / COMPLICATIONS NOR THE ONGOING SYMPTOMS / COMPLICATIONS THAT SHE REPORTED.
A PATIENT CONTACTED (B)(4), SMITH & NEPHEW'S CUSTOMER SERVICE, TO EXPRESS HER DISSATISFACTION RELATING TO A SMITH & NEPHEW REPRESENTATIVE REPORTEDLY ADVISING A PHYSICIAN TO PLACE OASIS ON HER INFECTED WOUND. THE PATIENT HAS A WOUND ON HER LOWER LEFT LEG WITH AN ETIOLOGY OF AN INSECT BITE. THE DATE OF ONSET WAS NOT INDICATED IN THE REPORT. THE PATIENT REPORTED THE WOUND HAD AN INFECTION PRESENT AND NEEDED DEBRIDEMENT. THE PATIENT FURTHER STATED THE SMITH & NEPHEW REPRESENTATIVE ADVISED THE PHYSICIAN TO JUST APPLY THE OASIS TO THE WOUND. THE PHYSICIAN APPLIED THE OASIS TO HER WOUND ON (B)(6) 2014. THE PATIENT INDICATED THE WOUND WAS NOT CLEANED AND THAT THE WOUND WAS ONLY WIPED OFF PRIOR TO APPLYING THE OASIS. ON (B)(6) 2014, THE AREA WAS SWOLLEN, DRAINING MORE, AND IT HAD AN ODOR. ON (B)(6) 2014, THE SMELL WAS WORSE, THE AREA WAS PAINFUL, AND THE WOUND WAS STILL DRAINING. ON (B)(6) 2014, THE PATIENT REMOVED THE OASIS. SHE WENT TO HER PHYSICIAN ON (B)(6) 2014, HER LEG WAS SOMEWHAT BETTER, BUT STILL DRAINING. ON (B)(6) 2014, THERE WAS NO ODOR PRESENT, BUT THERE WAS STILL SWELLING AND DRAINAGE. ON (B)(6) 2014, BACTROBAN WAS APPLIED TO THE WOUND AND THE WOUND WAS WRAPPED. THE PATIENT REPORTS SHE WAS HOSPITALIZED FOR 4 DAYS ((B)(6) 2014). DURING THIS TIME SHE HAD THE WOUND DEBRIDED AND HAD A WOUND PUMP TO WHICH SHE HAD AN ALLERGIC REACTION. THE PATIENT STATED SHE CURRENTLY USES 2 KOTEX PADS TO THE AREA TO ABSORB THE DRAINAGE AND THAT THE EDEMA DRIPS OUT OF THE WOUND AS THE WOUND CONTINUES TO DRAIN. THE PATIENT ALLEGES THAT WITH THE OASIS SHE DEVELOPED 2 ULCERS ON THE OTHER SIDE OF THE LEG. SHE STATED AT ONE POINT HER LEG WAS SWOLLEN TO 28 INCHES. CURRENTLY THE PATIENT HAS A DIAGNOSIS (EARLY TO MID-OCTOBER) OF A PSEUDOMONAS INFECTION AND SHE IS ON AN ANTIBIOTIC (CIPRO) ORALLY. REPORTEDLY THE PSEUDOMONAS WAS CONFIRMED VIA WOUND CULTURE. UPDATE: THE PATIENT MADE CONTACT WITH THE DISTRIBUTOR ON 10/19/2015. THE PATIENT INDICATED THAT THE PREVIOUSLY REPORTED PSEUDOMONAS INFECTION WAS ONGOING. THE PATIENT STARTED COUMADIN IN MARCH 2015 DUE TO A POSSIBLE BLOOD CLOT IN HER RIGHT LUNG. UPON STARTING THE COUMADIN, THE PATIENT DISCONTINUED THE ANTIBIOTIC CIPRO DUE TO AN INCREASED RISK FOR BLEEDING WHEN TAKEN WHILE ON COUMADIN. THE PATIENT INDICATED SHE WAS NOT CURRENTLY ON ANY ANTIBIOTIC THERAPY FOR THE PSEUDOMONAS INFECTION. THE PATIENT ALSO REPORTED SHE EXPERIENCES CONTINUED SWELLING IN HER LEG, CONTINUED PAIN IN THE LEG, CONTINUED DRAINAGE FROM THE WOUNDS, AND HAS NON-HEALING OF TWO (2) ULCERS.
A PATIENT CONTACTED PROSAR, SMITH & NEPHEW'S CUSTOMER SERVICE, TO EXPRESS HER DISSATISFACTION RELATING TO A SMITH & NEPHEW REPRESENTATIVE REPORTEDLY ADVISING A PHYSICIAN TO PLACE OASIS ON HER INFECTED WOUND. THE PATIENT HAS A WOUND ON HER LOWER LEFT LEG WITH AN ETIOLOGY OF AN INSECT BITE. THE DATE OF ONSET WAS NOT INDICATED IN THE REPORT. THE PATIENT REPORTED THE WOUND HAD AN INFECTION PRESENT AND NEEDED DEBRIDEMENT. THE PATIENT FURTHER STATED THE SMITH & NEPHEW REPRESENTATIVE ADVISED THE PHYSICIAN TO JUST APPLY THE OASIS TO THE WOUND. THE PHYSICIAN APPLIED THE OASIS TO HER WOUND ON (B)(6) 2014. THE PATIENT INDICATED THE WOUND WAS NOT CLEANED AND THAT THE WOUND WAS ONLY WIPED OFF PRIOR TO APPLYING THE OASIS. ON (B)(6) 2014, THE AREA WAS SWOLLEN, DRAINING MORE, AND IT HAD AN ODOR. ON (B)(6) 2014, THE SMELL WAS WORSE, THE AREA WAS PAINFUL, AND THE WOUND WAS STILL DRAINING. ON (B)(6) 2014, THE PATIENT REMOVED THE OASIS. SHE WENT TO HER PHYSICIAN ON (B)(6) 2014, HER LEG WAS SOMEWHAT BETTER, BUT STILL DRAINING. ON (B)(6) 2014, THERE WAS NO ODOR PRESENT, BUT THERE WAS STILL SWELLING AND DRAINAGE. ON (B)(6) 2014, BACTROBAN WAS APPLIED TO THE WOUND AND THE WOUND WAS WRAPPED. THE PATIENT REPORTS SHE WAS HOSPITALIZED FOR 4 DAYS ((B)(6) 2014 TO (B)(6) 2014). DURING THIS TIME SHE HAD THE WOUND DEBRIDED AND HAD A WOUND PUMP TO WHICH SHE HAD AN ALLERGIC REACTION. THE PATIENT STATED SHE CURRENTLY USES 2 (B)(6) PADS TO THE AREA TO ABSORB THE DRAINAGE AND THAT THE EDEMA DRIPS OUT OF THE WOUND AS THE WOUND CONTINUES TO DRAIN. THE PATIENT ALLEGES THAT WITH THE OASIS SHE DEVELOPED 2 ULCERS ON THE OTHER SIDE OF THE LEG. SHE STATED AT ONE POINT HER LEG WAS SWOLLEN TO 28 INCHES. CURRENTLY THE PATIENT HAS A DIAGNOSIS (EARLY TO MID-OCTOBER) OF A PSEUDOMONAS INFECTION AND SHE IS ON AN ANTIBIOTIC (CIPRO) ORALLY. REPORTEDLY THE PSEUDOMONAS WAS CONFIRMED VIA WOUND CULTURE. UPDATE: THE PATIENT MADE CONTACT WITH THE DISTRIBUTOR ON (B)(6) 2015. THE PATIENT INDICATED THAT THE PREVIOUSLY REPORTED PSEUDOMONAS INFECTION WAS ONGOING. THE PATIENT STARTED COUMADIN IN (B)(6) 2015 DUE TO A POSSIBLE BLOOD CLOT IN HER RIGHT LUNG. UPON STARTING THE COUMADIN, THE PATIENT DISCONTINUED THE ANTIBIOTIC CIPRO DUE TO AN INCREASED RISK FOR BLEEDING WHEN TAKEN WHILE ON COUMADIN. THE PATIENT INDICATED SHE WAS NOT CURRENTLY ON ANY ANTIBIOTIC THERAPY FOR THE PSEUDOMONAS INFECTION. THE PATIENT ALSO REPORTED SHE EXPERIENCES CONTINUED SWELLING IN HER LEG, CONTINUED PAIN IN THE LEG, CONTINUED DRAINAGE FROM THE WOUNDS, AND HAS NON-HEALING OF TWO (2) ULCERS. UPDATE #2: THE PATIENT CONTACTED THE DISTRIBUTOR ON (B)(6) 2015. THE PATIENT REPORTED THAT THE LEG HAS BROKE OUT AND SHE HAS BEEN FIGHTING AN INFECTION. THE PATIENT REPORTED BEING HOSPITALIZED TWICE FOR THIS WOUND. SHE REPORTS A PSEUDOMONAS INFECTION IN THE WOUND AT THIS TIME. CALLER REPORTS BEING RECENTLY DISCHARGED FROM THE HOSPITAL FROM A WOUND DEBRIDEMENT. THE PATIENT REPORTED THAT SINCE HER LAST CONTACT, THE WOUND HAS MORE PAIN, MORE DRAINAGE, AND HAS INCREASED IN SIZE.
A PATIENT CONTACTED (B)(4) CUSTOMER SERVICE, TO EXPRESS HER DISSATISFACTION RELATED TO A (B)(4) REPRESENTATIVE REPORTEDLY ADVISING A PHYSICIAN TO PLACE OASIS ON HER INFECTED WOUND. THE PATIENT HAS A WOUND ON HER LOWER LEG WITH AN ETIOLOGY OF AN INSECT BITE. THE DATE OF ONSET WAS NOT INDICATED IN THE REPORT. THE PATIENT REPORTED THE WOUND HAD A INFECTION PRESENT AND NEEDED DEBRIDEMENT. THE PATIENT FURTHER STATED THE (B)(4) REPRESENTATIVE ADVISED THE PHYSICIAN TO JUST APPLY THE OASIS TO THE WOUND. THE PHYSICIAN APPLIED THE OASIS TO HER WOUND ON (B)(6) 2014. THE PATIENT INDICATED THE WOUND WAS NOT CLEANED AND THAT THE WOULD WAS ONLY WIPED OFF PRIOR TO APPLYING OASIS. ON (B)(6) 2014, THE AREA WAS SWOLLEN, DRAINING MORE, AND IT HAD AN ODOR. ON (B)(6) 2014, THE SMELL WAS WORSE; THE AREA WAS PAINFUL, AND THE WOUND WAS STILL DRAINING. ON (B)(6) 2014, THE PATIENT REMOVED THE OASIS. SHE WENT TO HER PHYSICIAN ON (B)(6) 2014, HER LEG WAS SOMEWHAT BETTER, BUT STILL DRAINING. ON (B)(6) 2014, THERE WAS NO ODOR PRESENT, BUT THERE WAS STILL SWELLING AND DRAINAGE. ON (B)(6) 2014, BACTROBAN WAS APPLIED TO THE WOUND AND THE WOUND WAS WRAPPED. THE PATIENT REPORTS SHE WAS HOSPITALIZED FOR 4 DAYS ((B)(6) 2014). DURING THAT TIME, SHE HAD THE WOUND DEBRIDED AND HAD WOUND PUMP TO WHICH SHE HAD AN ALLERGIC REACTION. THE PATIENT STATED SHE CURRENTLY USES 2 (B)(6) PADS TO THE AREA TO ABSORB THE DRAINAGE AND THAT THE EDEMA DRIPS OUT OF THE WOUND AS THE WOUND CONTINUES TO DRAIN. THE PATIENT ALLEGES THAT WITH THE OASIS, SHE DEVELOPED 2 ULCERS ON THE OTHER SIDE OF THE LEG. SHE STATED AT ONE POINT, HER LEG WAS SWOLLEN TO 28 INCHES. CURRENTLY, THE PATIENT HAS A DIAGNOSIS (EARLY TO (B)(6)) OF A PSEUDOMONAS INFECTION AND SHE IS ON AN ANTIBIOTIC (CIPRO) ORALLY. REPORTEDLY, THE PSEUDOMONAS WAS CONFIRMED VIA WOUND CULTURE. AS OF (B)(6) 2014, THE PATIENT INDICATED THE SWELLING OF HER LEG, DRAINAGE, PAIN FROM THE WOUND, AND ULCERS ON THE LEG ARE ONGOING. SHE INDICATED THE NECROSIS RESOLVED WITH DISCONTINUATION OF THE PRODUCT AND THE WOUND DEBRIDEMENT. THE PATIENT FOLLOWED-UP WITH HER PHYSICIAN ON (B)(6) 2014 AND THERE WERE NO NEW FINDINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 717784 | OASIS ULTRA N/A TRI-LAYER MATRIX | OASIS | KGN | COOK BIOTECH | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| L| R |