GELFOAM
Report
- Report Number
- 1810189-2023-00004
- Event Type
- Death
- Date Received
- April 19, 2023
- Report Date
- April 11, 2023
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 11DEC2023 FOR ABSORBABLE GELATIN: CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO 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. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY.
EVENT VERBATIM [PREFERRED TERM] ONE PATIENT HAD ICA LACERATION AND SUBSEQUENTLY DEVELOPED POSTOPERATIVE HEMIPLEGIA AND DIED [ARTERIAL INJURY], ONE PATIENT HAD ICA LACERATION AND SUBSEQUENTLY DEVELOPED POSTOPERATIVE HEMIPLEGIA AND DIED [HEMIPLEGIA], DIED IN THE EARLY POSTOPERATIVE PERIOD, RELATED TO EXCESSIVE BLEEDING, DEARH WAS DIRECTLY RELATED TO SURGERY [POST PROCEDURAL HAEMORRHAGE], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "CAVERNOUS HEMANGIOMA OF CAVERNOUS SINUS: AN OUTCOME REPORT OF 45 SURGICALLY TREATED PATIENTS", WORLD NEUROSURGERY, 2022; VOL:159, PGS:381-389, DOI:(B)(6). A PATIENT (NO QUALIFIERS PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM, PFIZER INC, NEWYORK, USA), FOR HAEMOSTASIS. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "CAVERNOUS HEMANGIOMA OF CAVERNOUS SINUS" (UNSPECIFIED IF ONGOING); "HEADACHE" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: ARTERIAL INJURY (DEATH), HEMIPLEGIA (DEATH), OUTCOME "FATAL" AND ALL DESCRIBED AS "ONE PATIENT HAD ICA LACERATION AND SUBSEQUENTLY DEVELOPED POSTOPERATIVE HEMIPLEGIA AND DIED"; POST PROCEDURAL HAEMORRHAGE (DEATH), OUTCOME "FATAL", DESCRIBED AS "DIED IN THE EARLY POSTOPERATIVE PERIOD, RELATED TO EXCESSIVE BLEEDING, DEATH WAS DIRECTLY RELATED TO SURGERY". THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "ONE PATIENT HAD ICA LACERATION AND SUBSEQUENTLY DEVELOPED POSTOPERATIVE HEMIPLEGIA AND DIED", "DIED IN THE EARLY POSTOPERATIVE PERIOD, RELATED TO EXCESSIVE BLEEDING, DEARH WAS DIRECTLY RELATED TO SURGERY". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON THE INFORMATION CURRENTLY AVAILABLE, THERE IS A REASONABLE POSSIBILITY OF A CAUSAL ASSOCIATION BETWEEN THE REPORTED ADVERSE EVENTS AND THE SUSPECT PRODUCT ABSORBABLE GELATIN (GELFOAM). IT WAS REPORTED THAT "PATIENT HAD ICA LACERATION AND SUBSEQUENTLY DEVELOPED POSTOPERATIVE HEMIPLEGIA AND DIED."
EVENT VERBATIM [PREFERRED TERM] ONE PATIENT HAD ICA LACERATION AND SUBSEQUENTLY DEVELOPED POSTOPERATIVE HEMIPLEGIA AND DIED [ARTERIAL INJURY], ONE PATIENT HAD ICA LACERATION AND SUBSEQUENTLY DEVELOPED POSTOPERATIVE HEMIPLEGIA AND DIED [HEMIPLEGIA], DIED IN THE EARLY POSTOPERATIVE PERIOD, RELATED TO EXCESSIVE BLEEDING, DEARH WAS DIRECTLY RELATED TO SURGERY [POST PROCEDURAL HAEMORRHAGE], , NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "CAVERNOUS HEMANGIOMA OF CAVERNOUS SINUS: AN OUTCOME REPORT OF 45 SURGICALLY TREATED PATIENTS", WORLD NEUROSURGERY, 2022; VOL:159, PGS:381-389, DOI:10.1016/J.WNEU.2021.09.120. A PATIENT (NO QUALIFIERS PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR HAEMOSTASIS. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "CAVERNOUS HEMANGIOMA OF CAVERNOUS SINUS" (UNSPECIFIED IF ONGOING); "HEADACHE" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: ARTERIAL INJURY (DEATH), HEMIPLEGIA (DEATH), OUTCOME "FATAL" AND ALL DESCRIBED AS "ONE PATIENT HAD ICA LACERATION AND SUBSEQUENTLY DEVELOPED POSTOPERATIVE HEMIPLEGIA AND DIED"; POST PROCEDURAL HAEMORRHAGE (DEATH), OUTCOME "FATAL", DESCRIBED AS "DIED IN THE EARLY POSTOPERATIVE PERIOD, RELATED TO EXCESSIVE BLEEDING, DEARH WAS DIRECTLY RELATED TO SURGERY". THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "ONE PATIENT HAD ICA LACERATION AND SUBSEQUENTLY DEVELOPED POSTOPERATIVE HEMIPLEGIA AND DIED", "DIED IN THE EARLY POSTOPERATIVE PERIOD, RELATED TO EXCESSIVE BLEEDING, DEARH WAS DIRECTLY RELATED TO SURGERY". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON (B)(6) 2023 FOR ABSORBABLE GELATIN: CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO 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. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (11DEC2023): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS., COMMENT: BASED ON THE INFORMATION CURRENTLY AVAILABLE, THERE IS A REASONABLE POSSIBILITY OF A CAUSAL ASSOCIATION BETWEEN THE REPORTED ADVERSE EVENTS AND THE SUSPECT PRODUCT ABSORBABLE GELATIN (GELFOAM). IT WAS REPORTED THAT "PATIENT HAD ICA LACERATION AND SUBSEQUENTLY DEVELOPED POSTOPERATIVE HEMIPLEGIA AND DIED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1372836 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |