NOVOSORB BTM
Report
- Report Number
- 3007886187-2021-00007
- Event Type
- Injury
- Date Received
- November 28, 2021
- Date of Event
- November 1, 2021
- Report Date
- December 23, 2021
- Manufacturer
- POLYNOVO BIOMATERIALS PTY LTD
- Product Code
- FRO
- PMA / PMN Number
- K172140
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CAUSALITY UPDATED FROM 'NOT PROVIDED' TO 'NOT RELATED'. EVENT OUTCOME UPDATED TO 'RESOLVED' FROM 'NOT RESOLVED'.
VARIOUS MEDICAL AND SURGICAL INTERVENTIONS REQUIRED TO MANAGE REPORTED EVENTS INCLUDING BLOOD TRANSFUSION, AND REMOVAL AND RE-APPLICATION OF BTM. EVENTS RELATED TO THE DEVICE AND EXPECTED PER THE IFU, THAT STATES UNDER CONTRAINDICATIONS, "NOVOSORB® BTM SHOULD BE APPLIED INTO WOUNDS ONLY AFTER EFFECTIVE HEMOSTASIS HAS BEEN AFFORDED."
VARIOUS MEDICAL AND SURGICAL INTERVENTIONS REQUIRED TO MANAGE REPORTED EVENTS INCLUDING BLOOD TRANSFUSION, AND REMOVAL AND RE-APPLICATION OF BTM. EVENTS RELATED TO THE DEVICE AND EXPECTED PER THE IFU, THAT STATES UNDER CONTRAINDICATIONS, "NOVOSORB® BTM SHOULD BE APPLIED INTO WOUNDS ONLY AFTER EFFECTIVE HEMOSTASIS HAS BEEN AFFORDED."
ADDITIONAL INFORMATION RECEIVED 04-DEC-12 VIA SALES: THE BURN FELLOW COMMENTED THAT "HE THOUGHT THE BLEEDING ISSUE HAD BEEN RESOLVED AND IT WAS SUSPECTED THAT THE ISSUE HAD BEEN DUE TO HYPERTHERMIA IN THE OPERATING ROOM DURING APPLICATION.". IT WAS FURTHER STATED THAT THE ISSUE WAS PATIENT SPECIFIC AND DUE TO THE TYPE OF INJURY. THE DOCTORS EXCISED BOTH THE FRONT AND THE BACK OF THE PATIENT AT THE SAME TIME AND DID NOT STAGE THE EXCISIONS. IT WAS STATED THAT THIS WAS DUE TO THE NATURE OF THE INJURY AND WAS NOT A BTM ISSUE. IT WAS REPORTED THAT THE PATIENT ALSO HAD HYPERTHERMIA DURING SURGERY. IT WAS FURTHER STATED THAT SOME OF THE BURN WAS ALLOGRAFTED AND SOME HAD BTM IMPLANTED.
THE CASE DESCRIBES THE PATIENT WAS IMPLANTED WITH BTM USING STAPLES TO THE ANTERIOR TRUNK AND BACK AND SOME ANTERIOR SHOULDERS AND UPPER ARMS ON FOR AN ACUTE BURN AND "EXPERIENCED EXCESSIVE BLEEDING", MULTIPLE HEMATOMAS. THE WOUND SIZE WAS 50.5% TBSA. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED ISSUES "WITH EXCESSIVE BLEEDING". BTM WAS INITIALLY IMPLANTED AND A NON-ADHERENT PROPHYLACTIC SILVER ANTIMICROBIAL AND ABSORBENT DRESSING WERE USED. IT WAS REPORTED THAT HAEMOSTASIS HAD BEEN ACHIEVED WITH EPINEPHRINE AT TIME OF INITIAL APPLICATION. "WITHIN DAYS OF INITIAL PLACEMENT" THE PRODUCT WAS REVISED DUE TO BLEEDING. IT WAS REPORTED THAT THERE WAS SUSPECTED BLEEDING THROUGH DRESSINGS, AND MULTIPLE HEMATOMAS. AFTER REVISION PRODUCT WAS PLACED, THE PATIENT WAS STABLE FOR 3 DAYS WITH NO BLEEDING ISSUES. HOWEVER, EXCESSIVE BLEEDING WAS OBSERVED AGAIN. SURGICAL AND MEDICAL INTERVENTION WAS REQUIRED WITH TAKE DOWN OF BTM AND STABILIZE BEFORE REAPPLICATION. THERE IS NOW "SUSPECTED HEMATOMAS IN MULTIPLE AREAS, AND CONCERN OVER LOSING BTM AGAIN". THERE ARE CONCERNS OVER HIGH VOLUME USE OF UNITS OF BLOOD WITH PATIENT.. THE PATIENT INITIALLY HAD BTM IMPLANTED AND TWO SURGERIES WERE REQUIRED, ONE IN THE MORNING AND THE OTHER IN THE AFTERNOON OF THE SAME DAY. THE REPRESENTATIVE REPORTED THAT THEY SUSPECT THE SECOND SURGERY WAS TO ADDRESS THE FIRST EPISODE OF SUSPECTED BLEEDING. A 3RD SURGERY WAS REQUIRED AS A RESULT OF SUSPECTED BLEEDING AND HEMATOMAS. HAEMOSTASIS WAS ACHIEVED AND BTM PLACED AGAIN. IT WAS REPORTED THAT IT IS UNKNOWN IF THE EVENTS ARE RELATED TO BTM YET. THIS FACILITY HAD DONE A NUMBER OF CASES WITH BTM AND HAS NOT EXPERIENCED WIDESPREAD BLEEDING ISSUES. THE REP STATED THAT THE CAUSE IS UNKNOWN, AND UNSURE IF THERE IS SOMETHING UNDERLYING WITH PATIENT OR UNDIAGNOSED. IT WAS FURTHER STATED THAT IT IS NOT CLEAR IF THIS IS BURN RELATED, OR IF SOME OTHER FACTOR EXISTS. THE DOCTORS ON THE BURN TEAM ARE EXPERIENCED WITH MULTIPLE CASES OF BTM AND HAVEN'T SEEN ISSUES OF THIS NATURE IN PATIENTS SO NOT SURE IF IT IS USER RELATED. IT IS UNCLEAR WHY THE PATIENT WAS STABLE AND RELAPSED AGAIN. IT WAS CONFIRMED THAT THE FIRST SURGERY WAS A PLANNED DEBRIDEMENT AND EXCISION OF BURN WOUND AND PLACEMENT OF BTM. THE SECOND SURGERY ON THE SAME DAY WAS UNPLANNED, AND THEN THE THIRD SURGERY WAS UNPLANNED AS WELL. THE REPRESENTATIVE UNDERSTANDS THAT THEY "WERE TRYING TO GET A HANDLE ON THE EXCESSIVE BLEEDING AND THE SOURCE." THE REPRESENTATIVE STATED THAT THEY DON'T BELIEVE THE PATIENT WAS RECEIVING ANTICOAGULANTS. THE PATIENT HAD RECEIVED 40+ UNITS OF BLOOD, 15-16 UNITS OF FFP (FRESH FROZEN PLASMA), AND 1½ PACKS OF PLATELETS DURING THIS TREATMENT TIME. IT WAS REPORTED THAT THERE ARE STILL CONCERNS OVER HEMATOMAS, BUT THE PLAN AS OF THIS TIME IS TO LEAVE THEM IN PLACE AS THEY ARE ACTING AS A CLOT AND MONITOR CLOSELY. LOT NUMBER OF THE DEVICE USED ARE AS FOLLOWS: 200731L1, 200504L3, 210125L1, AND 210302L3 .
THE CASE DESCRIBES THE PATIENT WAS IMPLANTED WITH BTM USING STAPLES TO THE ANTERIOR TRUNK AND BACK AND SOME ANTERIOR SHOULDERS AND UPPER ARMS ON FOR AN ACUTE BURN AND "EXPERIENCED EXCESSIVE BLEEDING", MULTIPLE HEMATOMAS. THE WOUND SIZE WAS 50.5% TBSA. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED ISSUES "WITH EXCESSIVE BLEEDING". BTM WAS INITIALLY IMPLANTED AND A NON-ADHERENT PROPHYLACTIC SILVER ANTIMICROBIAL AND ABSORBENT DRESSING WERE USED. IT WAS REPORTED THAT HAEMOSTASIS HAD BEEN ACHIEVED WITH EPINEPHRINE AT TIME OF INITIAL APPLICATION. "WITHIN DAYS OF INITIAL PLACEMENT" THE PRODUCT WAS REVISED DUE TO BLEEDING. IT WAS REPORTED THAT THERE WAS SUSPECTED BLEEDING THROUGH DRESSINGS, AND MULTIPLE HEMATOMAS. AFTER REVISION PRODUCT WAS PLACED, THE PATIENT WAS STABLE FOR 3 DAYS WITH NO BLEEDING ISSUES. HOWEVER, EXCESSIVE BLEEDING WAS OBSERVED AGAIN. SURGICAL AND MEDICAL INTERVENTION WAS REQUIRED WITH TAKE DOWN OF BTM AND STABILIZE BEFORE REAPPLICATION. THERE IS NOW "SUSPECTED HEMATOMAS IN MULTIPLE AREAS, AND CONCERN OVER LOSING BTM AGAIN". THERE ARE CONCERNS OVER HIGH VOLUME USE OF UNITS OF BLOOD WITH PATIENT.. THE PATIENT INITIALLY HAD BTM IMPLANTED AND TWO SURGERIES WERE REQUIRED, ONE IN THE MORNING AND THE OTHER IN THE AFTERNOON OF THE SAME DAY. THE REPRESENTATIVE REPORTED THAT THEY SUSPECT THE SECOND SURGERY WAS TO ADDRESS THE FIRST EPISODE OF SUSPECTED BLEEDING. A 3RD SURGERY WAS REQUIRED AS A RESULT OF SUSPECTED BLEEDING AND HEMATOMAS. HAEMOSTASIS WAS ACHIEVED AND BTM PLACED AGAIN. IT WAS REPORTED THAT IT IS UNKNOWN IF THE EVENTS ARE RELATED TO BTM YET. THIS FACILITY HAD DONE A NUMBER OF CASES WITH BTM AND HAS NOT EXPERIENCED WIDESPREAD BLEEDING ISSUES. THE REP STATED THAT THE CAUSE IS UNKNOWN, AND UNSURE IF THERE IS SOMETHING UNDERLYING WITH PATIENT OR UNDIAGNOSED. IT WAS FURTHER STATED THAT IT IS NOT CLEAR IF THIS IS BURN RELATED, OR IF SOME OTHER FACTOR EXISTS. THE DOCTORS ON THE BURN TEAM ARE EXPERIENCED WITH MULTIPLE CASES OF BTM AND HAVEN'T SEEN ISSUES OF THIS NATURE IN PATIENTS SO NOT SURE IF IT IS USER RELATED. IT IS UNCLEAR WHY THE PATIENT WAS STABLE AND RELAPSED AGAIN. IT WAS CONFIRMED THAT THE FIRST SURGERY WAS A PLANNED DEBRIDEMENT AND EXCISION OF BURN WOUND AND PLACEMENT OF BTM. THE SECOND SURGERY ON THE SAME DAY WAS UNPLANNED, AND THEN THE THIRD SURGERY WAS UNPLANNED AS WELL. THE REPRESENTATIVE UNDERSTANDS THAT THEY "WERE TRYING TO GET A HANDLE ON THE EXCESSIVE BLEEDING AND THE SOURCE." THE REPRESENTATIVE STATED THAT THEY DON'T BELIEVE THE PATIENT WAS RECEIVING ANTICOAGULANTS. THE PATIENT HAD RECEIVED 40+ UNITS OF BLOOD, 15-16 UNITS OF FFP (FRESH FROZEN PLASMA), AND 1½ PACKS OF PLATELETS DURING THIS TREATMENT TIME. IT WAS REPORTED THAT THERE ARE STILL CONCERNS OVER HEMATOMAS, BUT THE PLAN AS OF THIS TIME IS TO LEAVE THEM IN PLACE AS THEY ARE ACTING AS A CLOT AND MONITOR CLOSELY. LOT NUMBER OF THE DEVICE USED ARE AS FOLLOWS: 200731L1, 200504L3, 210125L1, AND 210302L3 .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1777879 | NOVOSORB BTM | WOUND DRESSING | FRO | POLYNOVO BIOMATERIALS PTY LTD | BTM-1020, BTM-2040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Male | Required Intervention | EPINEPHRINE| EPINEPHRINE |