|
|
| Model Number 4350XL |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Purulent Discharge (1812); Cancer (3262)
|
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure? what are the name and date of index surgical procedure? what were the diagnosis and indication for the index surgical procedure? please provide any relevant patient history: patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates.Was there any intraoperative concurrent use of other products? what is the lot number? what was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? what was the intended use of the interceed? where was the surgicel used (on what tissue)? where was the interceed used (on what tissue)? how much surgicel was used during the procedure? was the surgicel product left in place? was the excess irrigated and removed? what were current symptoms following the index surgical procedure? onset date? were cultures performed? if yes, results? has any surgical or medical intervention been performed? what is physician¿s opinion as to the etiology of or contributing factors to the white and purulent area? do they believe it was caused due to the interceed and surgicel? was there an alleged deficiency of the surgicel or interceed that contributed to the patient¿s post-operative course? what is the patient¿s current status? what is the users experience w/ surgicel powder and other hemostatic agents? event related to mw # 2210968-2022-04250.
|
| |
|
Event Description
|
|
It was reported that a patient underwent an endometriosis procedure on an unknown date and absorbable adhesion barrier was used.After surgery, it was confirmed that the patient had a malignant tumor, so the abdominal cavity was observed again one month post-operatively.Then it was found that the area where the absorbable hemostat and the absorbable adhesion barrier product were used was white and purulent.The surgeon was made aware of the duration of absorption period of each product and that it should have been completely absorbed already based on the number of postoperative days.Additional information was requested.
|
| |
|
Manufacturer Narrative
|
|
Product complaint # (b)(4).Additional information was requested, and the following was obtained: 1.What are the name and date of index surgical procedure? procedure name is endometriosis surgery.Procedure was performed a month ago.2.What were the diagnosis and indication for the index surgical procedure? endometriosis.3.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? bleed.4.What was the intended use of the interceed? prevention of adhesions.5.Was the surgicel product left in place? was the excess irrigated and removed? the excess was not irrigated.6.What were current symptoms following the index surgical procedure? onset date? a month later, malignant tumor was observed.7.Has any surgical or medical intervention been performed? reoperation was performed, and the tissue became to be white was shaven.8.What is the patient¿s current status? no problem.The patient was diagnosed with malignancy one month after surgery, and reoperation was performed.There was no suppuration due to the powder, and only remained white.The remaining white part was removed.Details of what the whitened tissue were not available.When the powder was used in the first surgery, the surplus was not washed.There is no problem with the patient's condition after reoperation.The following information was requested, but unavailable: 1.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure? unknown.2.Please provide any relevant patient history: patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates.Unknown.3.Was there any intraoperative concurrent use of other products? unknown.4.What is the lot number? unknown in both product.5.Where was the surgicel used (on what tissue)? unknown.6.Where was the interceed used (on what tissue)? unknown.7.How much surgicel was used during the procedure? unknown.8.Were cultures performed? if yes, results? unknown.9.What is physician¿s opinion as to the etiology of or contributing factors to the white and purulent area? do they believe it was caused due to the interceed and surgicel? unknown.10.Was there an alleged deficiency of the surgicel or interceed that contributed to the patient¿s post-operative course? unknown.11.What is the users experience w/ surgicel powder and other hemostatic agents? unknown.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected information: h6.Health effect - impact code.
|
| |
|
Search Alerts/Recalls
|
|
|
