SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
Report
- Report Number
- 2210968-2018-77390
- Event Type
- Injury
- Date Received
- November 28, 2018
- Report Date
- November 2, 2018
- Manufacturer
- ETHICON INC.
- Product Code
- LMF
- PMA / PMN Number
- N12159
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
PRODUCT COMPLAINT # (B)(4). DATE SENT TO FDA: 11/29/2018. ADDITIONAL INFORMATION: ARTICLE LOCATED: HTTP://DX.DOI.ORG/10.21037/QIMS.2018.09.04. TITLE : HAEMOSTATIC MATERIAL (SURGICEL®) MIMICKING RESIDUAL TUMOUR: MAGNETIC RESONANCE IMAGING FINDINGS IN OPERATED PEDIATRIC NEURO-ONCOLOGY CASES AUTHOR : SERENA STAGLIANÒ, FELICE D¿ARCO, AI PENG TAN, OWASE JEELANI, GIOVANNI MORANA, KSHITIJ MANKAD . CITATION: QUANT IMAGING MED SURG. 2018; 8(9): 971-978. DOI: 10.21037/QIMS.2018.09.04.
PRODUCT COMPLAINT #: (B)(4). ADDITIONAL INFORMATION RECEIVED INDICATES THAT THIS EVENT DOES NOT MEET REPORTING SERIOUS INJURY CRITERIA. THIS EVENT THEREFORE IS NOT REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOCTOR / AUTHOR REPORTS: I WOULD LIKE TO HIGHLIGHT THAT THIS PAPER WAS TO HIGHLIGHT A RADIOLOGICAL INTERPRETATION PROBLEM, NOTHING TO DO WITH YOUR PRODUCT AND DOES NOT BELIEVE THERE IS ANY PRODUCT DEFICIENCY.
(B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? REFERENCE : HAEMOSTATIC MATERIAL (SURGICEL®) MIMICKING RESIDUAL TUMOUR: MAGNETIC RESONANCE IMAGING FINDINGS IN OPERATED PEDIATRIC NEURO-ONCOLOGY CASES AUTHOR : SERENA STAGLIANÒ, FELICE D¿ARCO, AI PENG TAN, OWASE JEELANI, GIOVANNI MORANA, KSHITIJ MANKAD CITATION: QUANT IMAGING MED SURG. 2018; 8(9): 971-978. DOI: 10.21037/QIMS.2018.09.04.
IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED: HAEMOSTATIC MATERIAL (SURGICEL®) MIMICKING RESIDUAL TUMOUR: MAGNETIC RESONANCE IMAGING FINDINGS IN OPERATED PEDIATRIC NEURO-ONCOLOGY CASES. THE AIM OF THIS PAPER WAS TO REPORT THREE NEURO-ONCOLOGIC PEDIATRIC CASES WHERE THE PRESENCE OF SURGICEL (ETHICON) IN THE SURGICAL BED CAUSED A DIAGNOSTIC CHALLENGE AND WAS INITIALLY MISDIAGNOSED AS TUMOR RESIDUUM/RECURRENCE. CASE 1, A (B)(6)-YEAR-OLD GIRL WITH A MIXED SOLID-CYSTIC RETRO-CHIASMATIC SUPRASELLAR MASS CENTERED AT THE HYPOTHALAMUS WITH COMPRESSION OF THE OPTIC CHIASM WAS PRESENTED. A DEBULKING SURGERY WAS PERFORMED TO RELIEVE THE COMPRESSION UPON THE OPTIC CHIASM AND OBTAIN TISSUE FOR HISTOPATHOLOGICAL ANALYSIS. SURGICEL (ETHICON) HEMOSTATIC AGENT WAS USED DURING THE PROCEDURE. DURING THE FOLLOW-UP MRI, A DILEMMA BETWEEN MATURING BLOOD CLOT AND RESIDUAL/RECURRENT TUMOR WAS OBSERVED AND A SECOND-LOOK SURGERY WAS PERFORMED. HISTOLOGICAL ANALYSIS SHOWED LACK OF TUMORAL CELLS AND EVIDENCE OF SURGICEL (ETHICON) FOREIGN MATERIAL WITH GRANULOMATOUS REACTION. MRI AFTER THE SURGERY REVEALED NO RESIDUAL ABNORMAL TISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 949218 | SURGICEL ABSORBABLE HEMOSTAT UNKNOWN | HEMOSTATIC AGENT, ABSORBABLE | LMF | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Required Intervention |