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| Model Number 4350XL |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Fever (1858); Pain (1994); Peritonitis (2252); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).Component code: (b)(4) device not returned.Health effect: clinical code: crp was high.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.Additional information was requested, and the following was obtained: what is the most current patient status? the patient has been discharged from the hospital and being followed up.(at present, loxonin is prescribed, and the condition is stable).The patient is (b)(6) female.[health injury details]: hospitalization period was prolonged.The patient had fever and pain.Details of the pain are unknown.The patient was scheduled for surgery on wednesday and discharge on monday of the following week, so the patient's temperature was measured on sunday night.Because the body temperature was in the 38 degree range, crp level was measured by blood sampling.Crp level was 1.5, which was not a high number and there was no possibility of abscess.(the white blood cell count was in the 9000 ~ 10,000 s, which was not very high.) as pyrexia persisted, the hospitalization period was prolonged and antipyretic measures with the prescription of loxonin were continued.Although there were findings of peritonitis, no such symptoms were observed.On wednesday, 12 days after the surgery, the patient was discharged because she had no fever anymore.Crp level was 1.5 and the white blood cell count was in the 9000 ~ 10,000 s.Since the number was not so high and there were no symptoms of peritonitis, it was judged to be non-serious.Unlike usual cases, a manipulator was used, and it is impossible to identify which products such as powder and interceed affected or did not affect.Enucleation was performed for irregular ovarian abscess.After recovery from postoperative anesthesia, the patient complained of pain.The patient may have complained of pain due to poor anesthesia management on that day.The patient was found to have pyrexia by body temperature measurement before discharge, crp 1.5.Prolonged hospitalization, antipyretic treatment was performed, and a follow-up observation was performed.When the patient's temperature was measured on sunday of the following week, the fever showed a downward tendency.The patient was discharged on wednesday.Manipulator, interceed, and surgicel were concomitantly used.The cause of this event has not been identified.The surgeon commented that in this case, a manipulator was used because of strong adhesion, although it didn¿t protrude into the abdominal cavity, bacteria sometimes enter the abdominal cavity via the fallopian tube, causing inflammation.A drain was placed just in case.Surgicel powder was applied to the douglas' pouch at the site of enucleation of the pyoma.The excess was removed by washing.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.What is the procedure date (dd/mm/yyyy)? what date did the fever occur on (dd/mm/yyyy)? was there any medical or surgical intervention performed to treat the patient?(product removed; re-operation; re-closure; prescription medication)? if so, please specify.If medication was required, please clarify if it was prescription strength.Was the patient hospitalization stay extended as a result of this event? can you identify the lot numbers of the products that were used? event related to mw # 2210968-2022-05674.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that a patient underwent an endoscopic surgery for ovarian chocolate cysts on an unknown date and adhesion barrier was used.The patient¿s fever did not subside, and the white blood cell count was normal.Although even on the sixth day post-operatively crp was high and fever repeatedly went up and down by 38 degrees, hence the patient is still in the hospital.No adverse patient consequences were reported.Additional information was requested.
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Manufacturer Narrative
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Product complaint # (b)(4).Additional information was requested, and the following was obtained: 1.Has any additional surgical or medical intervention been performed? the discharge was delayed and follow up with loxoprofen sodium hydrate prescription.2.What is the patient¿s current status? stable and already be discharged.3.What date did the fever occur on (dd/mm/yyyy)? the procedure was on (b)(6) , and the fever was confirmed on next (b)(6) night.4.Was the patient hospitalization stay extended as a result of this event? yes the following information was requested, but unavailable: 1.What is the procedure date (dd/mm/yyyy)? 2.Can you identify the lot numbers of the products that were used? 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.1.Please provide the following patient demographic information, if available: weight, bmi at the time of index procedure? 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.3.Was there any intraoperative concurrent use of other products? 4.What were the diagnosis and indication for the index surgical procedure? 5.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? 6.How much surgicel was used during the procedure? 7.Were cultures performed? if yes, results? 8.What is physician¿s opinion as to the etiology of or contributing factors to this event? 9.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative fever and pain? 10.What is the users experience w/ surgicel powder and other hemostatic agents? 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.
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Manufacturer Narrative
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Product complaint # (b)(4).Additional information was requested, and the following was obtained: 1.Please provide the following patient demographic information, if available: weight, bmi at the time of index procedure? the patient is 26-year-old female.2.What were the diagnosis and indication for the index surgical procedure? ovarian chocolate cysts.3.Was there any intraoperative concurrent use of other products? manipulator, interceed, and surgicel were concomitantly used.4.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? used for douglas' pouch and resection part of ovarian cyst.5.How much surgicel was used during the procedure? =>unknown, but the excess was washed away.6.Has any additional surgical or medical intervention been performed? loxonin was prescribed.7.What is physician¿s opinion as to the etiology of or contributing factors to this event? unlike usual cases, a manipulator was used, and it is impossible to identify which products such as powder and interceed affected or did not affect.8.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative fever and pain? the surgeon said that what caused this matter.9.What is the patient¿s current status? the patient has been discharged from the hospital.10.Was the patient hospitalization stay extended as a result of this event? yes.The following information was requested, but unavailable: 1.What is the date of index surgical procedure? 2.What are the product code and lot number of the surgicel and interceed? 3.Were cultures performed? if yes, results?.4.What is the users experience w/ surgicel powder and other hemostatic agents? 5.What date did the fever occur on (dd/mm/yyyy)? 6.Can you identify the lot numbers of the products that were used? 7.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.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.
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Search Alerts/Recalls
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