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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FOSUN PHARMA USA INC. MEDICAL SWAB; NASOPHARYNGEAL SWAB

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FOSUN PHARMA USA INC. MEDICAL SWAB; NASOPHARYNGEAL SWAB Back to Search Results
Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)
Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Tachycardia (2095); Bowel Perforation (2668); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Event Description
This literature case, derived from an abstract, was received on 13-jul-2022.It described a 56-year-old male patient who developed perforation at the ileocecal anastomosis (pt: intestinal perforation) after accidental ingested sars-cov-2 nasopharyngeal swab (pt: accidental exposure to product) while self-testing for covid (covid-19).Case report: a 56-year-old male patient with an extensive surgical medical history presented at the emergency department with progressive abdominal pain two weeks after accidental sars-cov-2 swab ingestion.Case presentation: on presentation, the patient was tachycardic and had generalized abdominal tenderness.A computerised tomogram (ct) scan showed free intraperitoneal air and fatty infiltration of the ileocecal anastomosis (after an ileocoecal resection at the age of 46) continuing to the distal sigmoid.Emergency exploratory laparotomy revealed a covid swab in the abdominal cavity with an indurated area of the sigmoid without perforation.The post-operative care was uneventful, and the patient was dismissed after four days.Clinical discussion: due to his medical history and the fact he was advised to regularly self-test for covid, he routinely performed an oropharyngeal swab.Unfortunately, this resulted in swallowing the swab.A perforation tends to happen in regions of acute angulation, such as an anastomosis.Although the ct scan suggested the perforation was at the ileocecal anastomosis, no perforation was found during surgery, while the swab was found loose in the peritoneal cavity.Author's comment: initial treatment should focus on endoscopic removal.In the case of gastrointestinal perforation, surgery becomes the treatment of choice.A foreign body can migrate to the peritoneal cavity without peritonitis or visible perforation perioperative.Literature citation: holman fa, versluijs y, keekstra n.Intestine perforation by an accidental ingested sars-cov-2 nasopharyngeal swab; a case report.Int j surg case rep.2022 jul;96.Company comment: a 56-year-old patient developed perforation at the ileocecal anastomosis (intestinal perforation) after accidental ingestion of sars-cov-2 nasopharyngeal swab (accidental exposure to product) while self-testing for covid-19.In response to the event, the patient underwent surgical intervention.Considering the case information, the causality of intestinal perforation is assessed as possible with nasopharyngeal swab.Accidental exposure to product is considered listed and the causality is assessed as not applicable with nasopharyngeal swab.The case is considered serious due to the medical significance of intestinal perforation, hospitalization of the patient, and need for intervention.Intestinal perforation is unlisted as per uspi.Additional significant information was received on 25-jul-2022 from a full-text article.Case presentation: past surgical history: the patient in this case report had an extensive surgical past history.At the age of 38, the patient underwent laparoscopic gastric banding surgery for morbid obesity which was followed by an abdominoplasty two years later.At the age of 45, laparoscopic gastric bypass was performed.A year later he underwent surgery for a hernia cicatricalis and a laparoscopic cholecystectomy.Due to irritation of the colon by the gastric band catheter, an ileocecal resection was performed.This procedure was complicated by leakage of the lesser curvature, for what he underwent surgery to repair this leakage.At the age of 52, another correction hernia cicatricalis was performed.After that, he underwent surgical correction of a diaphragmatic hernia with a biologic mesh, which resulted in permanent right hemidiaphragm paralysis.Clinical presentation: this 56-year-old male was referred by the general practitioner (gp) to the emergency department (ed) of an academic hospital, with progressive severe abdominal pain over the past 4 h, two weeks after accidental ingestion of a severe acute respiratory syndrome coronavirus 2 (sars-cov-2) nasopharyngeal swab.During the omicron period, people were advised by the dutch ministry of health, welfare and sport to perform oropharyngeal tests in addition to nasal self-sampling, since there was evidence the sensitivity of the covid swab would be improved.Given his medical history, the patient was advised to perform regularly self-tests and reach deep in the pharynx.This resulted in an accidental ingestion for which patient had multiple consultations with his gp who expected an uneventful passage of the swab.At admission on the ed, the patient was afebrile and tachycardic with a pulse rate of 120/min.Physical examination showed diffuse abdominal pain with no clinical signs of generalized peritonitis.The laboratory parameters showed increased inflammatory markers (leukocytes: 17.7, c-reactive protein: 9) and further normal hematological, renal, and hepatic profiles.Subsequently, oral contrast-enhanced computed tomography (ct) demonstrated the presence of free intraperitoneal gas and fatty infiltrations around the ileocecal anastomosis with extension to the distal sigmoid colon.These radiological features suggested the diagnosis of intestinal perforation.The covid swab was not visible on the ct.Management and outcome: the patient was admitted to the hospital and taken to the operating room for emergency exploratory surgery by an experienced abdominal surgeon.He was found to have purulent abdominal fluid, but no intestinal contents.The covid swab was found in toto in the free abdominal cavity and was removed.No abnormalities were found around the anastomosis of the ileocecal resection and rest of the small intestines.The sigmoid had a distinct indurated area most likely the swab perforated through the wall and the perforation healed.No more perforations were observed during inspection.A surgical silicone drain was left in the abdominal cavity and was removed two days postoperative.In-hospital recovery was uneventful, and he was discharged after 4 days.Four weeks after discharge patient developed wound dehiscence which was treated with wound dressings.Author's comment: incidental ingestion of a foreign body was a common problem, and it could be critical and fatal.In this case, the patient developed gastrointestinal perforation as the result of ingestion of a sars-cov-2 nasopharyngeal swab.If a foreign body was ingested and detected, the first approach should be endoscopic removal.If endoscopy fails to remove it and there was a high risk of perforation, surgical removal should be considered before severe complications develop.Literature citation: holman fa, keekstra n, versluijs y.Intestine perforation by an accidental ingested sars-cov-2 nasopharyngeal swab; a case report.Int j surg case rep.2022 jul;96.Company comment: a 56-year-old patient developed perforation at the ileocecal anastomosis (intestinal perforation) after accidental ingestion of sars-cov-2 nasopharyngeal swab (accidental exposure to product) while self-testing for covid-19.In response to the event, the patient underwent surgical intervention.Considering the case information, the causality of intestinal perforation is assessed as possible with nasopharyngeal swab.Accidental exposure to product is considered listed and the causality is assessed as not applicable with nasopharyngeal swab.The case is considered serious due to the medical significance of intestinal perforation, hospitalization of the patient, and need for intervention.Intestinal perforation is unlisted as per uspi.
 
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Brand Name
MEDICAL SWAB
Type of Device
NASOPHARYNGEAL SWAB
Manufacturer (Section D)
FOSUN PHARMA USA INC.
suite 204
104 camegie center
princeton NJ 08540
MDR Report Key15181809
MDR Text Key297414086
Report Number3015145560-2022-00012
Device Sequence Number1
Product Code KXG
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/25/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age56 YR
Patient SexMale
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