ABSORBABLE GELATIN
Report
- Report Number
- 1810189-2021-00020
- Event Type
- Injury
- Date Received
- June 25, 2021
- Report Date
- June 7, 2021
- Manufacturer
- PFIZER, INC.
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
ON (B)(6)2021, THE PRODUCT QUALITY GROUP (PQC) REPORTED THE FOLLOWING CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT/NEGLIGIBLE-MINOR' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER (MANUFACTURING SITE) WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED.
EVENT VERBATIM [PREFERRED TERM] UTERINE ARTERY EMBOLIZATION [OFF LABEL USE], UTERINE NECROSIS [UTERINE NECROSIS], , NARRATIVE: THIS IS A LITERATURE REPORT FROM THE OFFICIAL JOURNAL OF THE JAPANESE SOCIETY OF INTERVENTIONAL RADIOLOGY, 2021, 36(S); P. 226, ENTITLED, 'A CASE OF UTERINE NECROSIS AFTER EMBOLIZATION OF THE UTERINE ARTERY WITH GELATIN SPONGE FRAGMENTS.' THE PATIENT WAS A 30-YEAR-OLD WOMAN. SHE WAS GRAVIDA 1 PARA 0. SHE WAS ADMITTED TO OUR HOSPITAL BECAUSE OF EARLY RUPTURE OF MEMBRANES. PROLONGATION OF THE SECOND-STAGE OF LABOR WAS NOTED, AND THE BABY WAS DELIVERED WITH FORCEPS. AFTER THE DELIVERY, PROGRESSION OF ANEMIA WAS NOTED. CONTRAST-ENHANCED CT REVEALED EXTRAVASCULAR LEAK TO THE INTRAUTERINE CAVITY AND PSEUDOANEURYSM IN THE RIGHT VAGINAL WALL. THEREFORE, EMBOLIZATION WAS PERFORMED URGENTLY. LEFT UTERINE ARTERY ANGIOGRAPHY REVEALED EXTRAVASCULAR LEAK OF THE CONTRAST AGENT TO THE UTERUS. EMBOLIZATION WAS PERFORMED WITH GELATIN SPONGE CUT INTO PIECES OF 1 TO 2 MM IN DIAMETER, AND RESOLUTION OF THE LEAK OF THE CONTRAST AGENT AND BLOOD STAGNATION WERE CONFIRMED. ALTHOUGH RIGHT UTERINE ARTERY ANGIOGRAPHY REVEALED NO OBVIOUS LEAK OF THE CONTRAST AGENT, MILD EMBOLIZATION WAS PERFORMED. RIGHT INTERNAL PUDENDAL ARTERY ANGIOGRAPHY SUGGESTED LEAK OF THE CONTRAST AGENT TO THE PERIPHERAL AREA. THEREFORE, EMBOLIZATION WAS PERFORMED. CT PERFORMED ON DAY 2 AFTER EMBOLIZATION REVEALED NO ACTIVE HEMORRHAGE IN THE UTERINE CAVITY. HOWEVER, THE CONTRAST WAS POORLY ENHANCED PARTIALLY IN THE UTERINE MUSCULAR WALL, WHICH WAS SUGGESTIVE OF THE IMPACT OF ISCHEMIA. PYREXIA AND INCREASED INFLAMMATORY REACTION WERE NOTED IN THE SUBSEQUENT CLINICAL COURSE, AND INTRAUTERINE INFECTION WAS SUSPECTED. DESPITE TREATMENT WITH ANTIBACTERIALS, PYREXIA AND INCREASED INFLAMMATORY REACTION WERE POORLY ALLEVIATED. ON DAY 15 AFTER EMBOLIZATION, DRAINAGE WAS PERFORMED FOR THE TREATMENT OF SUSPECTED PYOMETRA, AND CLOTTING BLOOD WAS DRAINED. HOWEVER, PYREXIA PERSISTED THEREAFTER, AND MRI WAS PERFORMED TO CHECK PRESENCE/ABSENCE OF NECROSIS OF UTERINE TISSUES. MRI REVEALED SWOLLEN MUSCULAR LAYER MAINLY IN THE PROXIMAL AREA OF THE ENDOMETRIUM, WHERE POORLY ENHANCED CONTRAST WAS NOTED. THEREFORE, UTERINE NECROSIS WAS SUSPECTED. ON DAY 23 AFTER EMBOLIZATION, LAPAROSCOPIC TOTAL HYSTERECTOMY WAS PERFORMED. PATHOLOGY REVEALED EXTENSIVE COAGULATIVE NECROSIS IN THE WALL OF THE UTERINE CORPUS. ONLY A PART OF THE ENDOMETRIA COULD BE OBSERVED, AND THE PATIENT WAS DIAGNOSED WITH UTERINE NECROSIS. THE PATIENT HAD A GOOD POSTOPERATIVE COURSE. PYREXIA AND INCREASED INFLAMMATORY REACTION WERE ALLEVIATED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. UTERINE NECROSIS AFTER UTERINE ARTERY EMBOLIZATION IS A RARE COMPLICATION. THERE ARE ONLY A FEW REPORTED CASES IN WHICH MRI HAS BEEN PERFORMED. WE EXPERIENCED AND HEREIN REPORT A CASE OF UTERINE NECROSIS AFTER UTERINE ARTERY EMBOLIZATION WITH GELATIN SPONGE FRAGMENTS WITH DIAGNOSTIC IMAGES AND SOME BIBLIOGRAPHIC CONSIDERATION. FOLLOW-UP ((B)(6)2021): THIS IS A FOLLOW-UP REPORT FROM THE PFIZER PRODUCT QUALITY GROUP (PQC) PROVIDING THE INVESTIGATION CONCLUSION. ON (B)(6)2021, THE PQC REPORTED THE FOLLOWING CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT/NEGLIGIBLE-MINOR' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER (MANUFACTURING SITE) WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. PFIZER IS A MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN IN THE COUNTRY OF INCIDENCE OR THE COUNTRY WHERE THE PRODUCT WAS PURCHASED (IF DIFFERENT). THIS MAY BE A DUPLICATE REPORT IF ANOTHER MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN HAS SUBMITTED THE SAME REPORT TO THE REGULATORY AUTHORITIES. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. COMPANY CASE COMMENT: BASED ON THE INFORMATION PROVIDED, POSTPARTUM CONTRAST-ENHANCED CT REVEALED EXTRAVASCULAR LEAK TO THE INTRAUTERINE CAVITY AND PSEUDOANEURYSM IN THE RIGHT VAGINAL WALL THEREFORE, EMBOLIZATION WAS PERFORMED URGENTLY. LEFT UTERINE ARTERY ANGIOGRAPHY REVEALED EXTRAVASCULAR LEAK OF THE CONTRAST AGENT TO THE UTERUS. EMBOLIZATION WAS PERFORMED WITH GELATIN SPONGE CUT INTO PIECES AND RESOLUTION OF THE LEAK OF THE CONTRAST AGENT AND BLOOD STAGNATION WERE CONFIRMED. ALTHOUGH RIGHT UTERINE ARTERY ANGIOGRAPHY REVEALED NO OBVIOUS LEAK OF THE CONTRAST AGENT, MILD EMBOLIZATION WAS PERFORMED. RIGHT INTERNAL PUDENDAL ARTERY ANGIOGRAPHY SUGGESTED LEAK OF THE CONTRAST AGENT TO THE PERIPHERAL AREA. THEREFORE, EMBOLIZATION WAS PERFORMED. CT PERFORMED ON DAY 2 AFTER EMBOLIZATION REVEALED NO ACTIVE HEMORRHAGE IN THE UTERINE CAVITY. PYREXIA AND INCREASED INFLAMMATORY REACTION WERE NOTED IN THE SUBSEQUENT CLINICAL COURSE, AND INTRAUTERINE INFECTION WAS SUSPECTED. DESPITE TREATMENT WITH ANTIBACTERIALS, PYREXIA AND INCREASED INFLAMMATORY REACTION WERE POORLY ALLEVIATED. PATHOLOGY REVEALED EXTENSIVE COAGULATIVE NECROSIS IN THE WALL OF THE UTERINE CORPUS. ONLY A PART OF THE ENDOMETRIA COULD BE OBSERVED, AND THE PATIENT WAS DIAGNOSED WITH UTERINE NECROSIS. THE PATIENT HAD A GOOD POSTOPERATIVE COURSE AND WAS DISCHARGED FROM THE HOSPITAL. UTERINE NECROSIS AFTER UTERINE ARTERY EMBOLIZATION IS A RARE COMPLICATION. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER DRUG IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE., COMMENT: BASED ON THE INFORMATION PROVIDED, POSTPARTUM CONTRAST-ENHANCED CT REVEALED EXTRAVASCULAR LEAK TO THE INTRAUTERINE CAVITY AND PSEUDOANEURYSM IN THE RIGHT VAGINAL WALL THEREFORE, EMBOLIZATION WAS PERFORMED URGENTLY. LEFT UTERINE ARTERY ANGIOGRAPHY REVEALED EXTRAVASCULAR LEAK OF THE CONTRAST AGENT TO THE UTERUS. EMBOLIZATION WAS PERFORMED WITH GELATIN SPONGE CUT INTO PIECES AND RESOLUTION OF THE LEAK OF THE CONTRAST AGENT AND BLOOD STAGNATION WERE CONFIRMED. ALTHOUGH RIGHT UTERINE ARTERY ANGIOGRAPHY REVEALED NO OBVIOUS LEAK OF THE CONTRAST AGENT, MILD EMBOLIZATION WAS PERFORMED. RIGHT INTERNAL PUDENDAL ARTERY ANGIOGRAPHY SUGGESTED LEAK OF THE CONTRAST AGENT TO THE PERIPHERAL AREA. THEREFORE, EMBOLIZATION WAS PERFORMED. CT PERFORMED ON DAY 2 AFTER EMBOLIZATION REVEALED NO ACTIVE HEMORRHAGE IN THE UTERINE CAVITY. PYREXIA AND INCREASED INFLAMMATORY REACTION WERE NOTED IN THE SUBSEQUENT CLINICAL COURSE, AND INTRAUTERINE INFECTION WAS SUSPECTED. DESPITE TREATMENT WITH ANTIBACTERIALS, PYREXIA AND INCREASED INFLAMMATORY REACTION WERE POORLY ALLEVIATED. PATHOLOGY REVEALED EXTENSIVE COAGULATIVE NECROSIS IN THE WALL OF THE UTERINE CORPUS. ONLY A PART OF THE ENDOMETRIA COULD BE OBSERVED, AND THE PATIENT WAS DIAGNOSED WITH UTERINE NECROSIS. THE PATIENT HAD A GOOD POSTOPERATIVE COURSE AND WAS DISCHARGED FROM THE HOSPITAL. UTERINE NECROSIS AFTER UTERINE ARTERY EMBOLIZATION IS A RARE COMPLICATION. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER DRUG IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
EVENT VERBATIM [PREFERRED TERM]. UTERINE ARTERY EMBOLIZATION [OFF LABEL USE], UTERINE NECROSIS [UTERINE NECROSIS], NARRATIVE: THIS IS A LITERATURE REPORT FROM THE OFFICIAL JOURNAL OF THE JAPANESE SOCIETY OF INTERVENTIONAL RADIOLOGY, 2021, 36(S); P. 226, ENTITLED, 'A CASE OF UTERINE NECROSIS AFTER EMBOLIZATION OF THE UTERINE ARTERY WITH GELATIN SPONGE FRAGMENTS.' THE PATIENT WAS A (B)(6) WOMAN. SHE WAS GRAVIDA 1 PARA 0. SHE WAS ADMITTED TO OUR HOSPITAL BECAUSE OF EARLY RUPTURE OF MEMBRANES. PROLONGATION OF THE SECOND-STAGE OF LABOR WAS NOTED, AND THE BABY WAS DELIVERED WITH FORCEPS. AFTER THE DELIVERY, PROGRESSION OF ANEMIA WAS NOTED. CONTRAST-ENHANCED CT REVEALED EXTRAVASCULAR LEAK TO THE INTRAUTERINE CAVITY AND PSEUDOANEURYSM IN THE RIGHT VAGINAL WALL. THEREFORE, EMBOLIZATION WAS PERFORMED URGENTLY. LEFT UTERINE ARTERY ANGIOGRAPHY REVEALED EXTRAVASCULAR LEAK OF THE CONTRAST AGENT TO THE UTERUS. EMBOLIZATION WAS PERFORMED WITH GELATIN SPONGE CUT INTO PIECES OF 1 TO 2 MM IN DIAMETER, AND RESOLUTION OF THE LEAK OF THE CONTRAST AGENT AND BLOOD STAGNATION WERE CONFIRMED. ALTHOUGH RIGHT UTERINE ARTERY ANGIOGRAPHY REVEALED NO OBVIOUS LEAK OF THE CONTRAST AGENT, MILD EMBOLIZATION WAS PERFORMED. RIGHT INTERNAL PUDENDAL ARTERY ANGIOGRAPHY SUGGESTED LEAK OF THE CONTRAST AGENT TO THE PERIPHERAL AREA. THEREFORE, EMBOLIZATION WAS PERFORMED. CT PERFORMED ON DAY 2 AFTER EMBOLIZATION REVEALED NO ACTIVE HEMORRHAGE IN THE UTERINE CAVITY. HOWEVER, THE CONTRAST WAS POORLY ENHANCED PARTIALLY IN THE UTERINE MUSCULAR WALL, WHICH WAS SUGGESTIVE OF THE IMPACT OF ISCHEMIA. PYREXIA AND INCREASED INFLAMMATORY REACTION WERE NOTED IN THE SUBSEQUENT CLINICAL COURSE, AND INTRAUTERINE INFECTION WAS SUSPECTED. DESPITE TREATMENT WITH ANTIBACTERIALS, PYREXIA AND INCREASED INFLAMMATORY REACTION WERE POORLY ALLEVIATED. ON DAY 15 AFTER EMBOLIZATION, DRAINAGE WAS PERFORMED FOR THE TREATMENT OF SUSPECTED PYOMETRA, AND CLOTTING BLOOD WAS DRAINED. HOWEVER, PYREXIA PERSISTED THEREAFTER, AND MRI WAS PERFORMED TO CHECK PRESENCE/ABSENCE OF NECROSIS OF UTERINE TISSUES. MRI REVEALED SWOLLEN MUSCULAR LAYER MAINLY IN THE PROXIMAL AREA OF THE ENDOMETRIUM, WHERE POORLY ENHANCED CONTRAST WAS NOTED. THEREFORE, UTERINE NECROSIS WAS SUSPECTED. ON DAY 23 AFTER EMBOLIZATION, LAPAROSCOPIC TOTAL HYSTERECTOMY WAS PERFORMED. PATHOLOGY REVEALED EXTENSIVE COAGULATIVE NECROSIS IN THE WALL OF THE UTERINE CORPUS. ONLY A PART OF THE ENDOMETRIA COULD BE OBSERVED, AND THE PATIENT WAS DIAGNOSED WITH UTERINE NECROSIS. THE PATIENT HAD A GOOD POSTOPERATIVE COURSE. PYREXIA AND INCREASED INFLAMMATORY REACTION WERE ALLEVIATED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. UTERINE NECROSIS AFTER UTERINE ARTERY EMBOLIZATION IS A RARE COMPLICATION. THERE ARE ONLY A FEW REPORTED CASES IN WHICH MRI HAS BEEN PERFORMED. WE EXPERIENCED AND HEREIN REPORT A CASE OF UTERINE NECROSIS AFTER UTERINE ARTERY EMBOLIZATION WITH GELATIN SPONGE FRAGMENTS WITH DIAGNOSTIC IMAGES AND SOME BIBLIOGRAPHIC CONSIDERATION. PFIZER IS A MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN IN THE COUNTRY OF INCIDENCE OR THE COUNTRY WHERE THE PRODUCT WAS PURCHASED (IF DIFFERENT). THIS MAY BE A DUPLICATE REPORT IF ANOTHER MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN HAS SUBMITTED THE SAME REPORT TO THE REGULATORY AUTHORITIES. BASED ON THE INFORMATION PROVIDED, POSTPARTUM CONTRAST-ENHANCED CT REVEALED EXTRAVASCULAR LEAK TO THE INTRAUTERINE CAVITY AND PSEUDOANEURYSM IN THE RIGHT VAGINAL WALL THEREFORE, EMBOLIZATION WAS PERFORMED URGENTLY. LEFT UTERINE ARTERY ANGIOGRAPHY REVEALED EXTRAVASCULAR LEAK OF THE CONTRAST AGENT TO THE UTERUS. EMBOLIZATION WAS PERFORMED WITH GELATIN SPONGE CUT INTO PIECES AND RESOLUTION OF THE LEAK OF THE CONTRAST AGENT AND BLOOD STAGNATION WERE CONFIRMED. ALTHOUGH RIGHT UTERINE ARTERY ANGIOGRAPHY REVEALED NO OBVIOUS LEAK OF THE CONTRAST AGENT, MILD EMBOLIZATION WAS PERFORMED. RIGHT INTERNAL PUDENDAL ARTERY ANGIOGRAPHY SUGGESTED LEAK OF THE CONTRAST AGENT TO THE PERIPHERAL AREA. THEREFORE, EMBOLIZATION WAS PERFORMED. CT PERFORMED ON DAY 2 AFTER EMBOLIZATION REVEALED NO ACTIVE HEMORRHAGE IN THE UTERINE CAVITY. PYREXIA AND INCREASED INFLAMMATORY REACTION WERE NOTED IN THE SUBSEQUENT CLINICAL COURSE, AND INTRAUTERINE INFECTION WAS SUSPECTED. DESPITE TREATMENT WITH ANTIBACTERIALS, PYREXIA AND INCREASED INFLAMMATORY REACTION WERE POORLY ALLEVIATED. PATHOLOGY REVEALED EXTENSIVE COAGULATIVE NECROSIS IN THE WALL OF THE UTERINE CORPUS. ONLY A PART OF THE ENDOMETRIA COULD BE OBSERVED, AND THE PATIENT WAS DIAGNOSED WITH UTERINE NECROSIS. THE PATIENT HAD A GOOD POSTOPERATIVE COURSE AND WAS DISCHARGED FROM THE HOSPITAL. UTERINE NECROSIS AFTER UTERINE ARTERY EMBOLIZATION IS A RARE COMPLICATION. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER DRUG IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE., BASED ON THE INFORMATION PROVIDED, POSTPARTUM CONTRAST-ENHANCED CT REVEALED EXTRAVASCULAR LEAK TO THE INTRAUTERINE CAVITY AND PSEUDOANEURYSM IN THE RIGHT VAGINAL WALL THEREFORE, EMBOLIZATION WAS PERFORMED URGENTLY. LEFT UTERINE ARTERY ANGIOGRAPHY REVEALED EXTRAVASCULAR LEAK OF THE CONTRAST AGENT TO THE UTERUS. EMBOLIZATION WAS PERFORMED WITH GELATIN SPONGE CUT INTO PIECES AND RESOLUTION OF THE LEAK OF THE CONTRAST AGENT AND BLOOD STAGNATION WERE CONFIRMED. ALTHOUGH RIGHT UTERINE ARTERY ANGIOGRAPHY REVEALED NO OBVIOUS LEAK OF THE CONTRAST AGENT, MILD EMBOLIZATION WAS PERFORMED. RIGHT INTERNAL PUDENDAL ARTERY ANGIOGRAPHY SUGGESTED LEAK OF THE CONTRAST AGENT TO THE PERIPHERAL AREA. THEREFORE, EMBOLIZATION WAS PERFORMED. CT PERFORMED ON DAY 2 AFTER EMBOLIZATION REVEALED NO ACTIVE HEMORRHAGE IN THE UTERINE CAVITY. PYREXIA AND INCREASED INFLAMMATORY REACTION WERE NOTED IN THE SUBSEQUENT CLINICAL COURSE, AND INTRAUTERINE INFECTION WAS SUSPECTED. DESPITE TREATMENT WITH ANTIBACTERIALS, PYREXIA AND INCREASED INFLAMMATORY REACTION WERE POORLY ALLEVIATED. PATHOLOGY REVEALED EXTENSIVE COAGULATIVE NECROSIS IN THE WALL OF THE UTERINE CORPUS. ONLY A PART OF THE ENDOMETRIA COULD BE OBSERVED, AND THE PATIENT WAS DIAGNOSED WITH UTERINE NECROSIS. THE PATIENT HAD A GOOD POSTOPERATIVE COURSE AND WAS DISCHARGED FROM THE HOSPITAL. UTERINE NECROSIS AFTER UTERINE ARTERY EMBOLIZATION IS A RARE COMPLICATION. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER DRUG IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 961304 | ABSORBABLE GELATIN | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R |