CulturaRecalls & reported problems across all models

We found 2 models of Cultura by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Sep 14, 2020 and Sep 30, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Cultura recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 16, 2020Terminated

   The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.

   Z-0454-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Cultura problems

Cultura models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cultura™ 00884450491102

  APPLICATOR, ABSORBENT TIPPED, STERILE
  1 recall0 reports
• Cultura™ 00884450495834

  APPLICATOR, ABSORBENT TIPPED, STERILE
  2 reports

Recent Cultura adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2020Fracture; Fracture

  THE ACCOUNT ALLEGES THAT A PATIENT WAS ADMITTED TO THE ED WITH LOWER BACK PAIN RADIATING INTO HIS UPPER LEGS BILATERALLY. THE PATIENT HAS A HISTORY OF CHRONIC THORACIC AND LUMBAR PAIN, ASSOCIATED VERTEBRAL HERNIATIONS, AND METHAMPHETAMINE INTRAVENOUS DRUG USE. THE PATIENT WAS TRANSFERRED FOR FURTHER PAIN EVALUATION AND INFECTIOUS ETIOLOGY / DEGENERATIVE CHANGES WITH LUMBAR RADICULOPATHY. PRIOR TO TRANSFER, COVID19 TESTING WAS ORDERED. AN RN PERFORMED COVID19 NASOPHARYNGEAL SWAB WITHIN THE LEFT ANTERIOR NARES. THE SWAB BROKE 4.5 CM FROM RED LINE WHERE SWAB NARROWS. THE PATIENT IMMEDIATELY SNIFFED, AND THE SWAB DISAPPEARED INTO NASOPHARYNGEAL CAVITY. THE EMERGENCY ROOM PHYSICIAN WAS NOTIFIED IMMEDIATELY. THE PATIENT WAS INSTRUCTED TO BLOW HIS NOSE IN ATTEMPTS TO EXPEL THE DETACHED TIP WITH NO SUCCESS. A NASAL SPECULUM WAS THEN USED TO TRY AND LOCATE THE DETACHED TIP WITH NO SUCCESS. THE PHYSICIAN WAS NOT ABLE TO LOCATE OR VISUALIZE THE SWAB. AN X-RAY WAS COMPLETED WITH NO IDENTIFICATION OF THE SWAB WITHIN THE NASOPHARYNGEAL CAVITY. AN ENT WAS CONSULTED, AND AFRIN WAS ADMINISTRATED FOR THE PATIENT'S CONGESTION. TREATMENT INITIATED WITHOUT RETRIEVAL OF THE SWAB AS WELL. THE PATIENT DEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10610672 ↗
• MalfunctionSep 14, 2020Break

  THE PATIENT ADMITTED TO THE ED WITH LOWER BACK PAIN RADIATING INTO BILATERAL UPPER LEGS. THE PATIENT HAS A HISTORY OF CHRONIC THORACIC AND LUMBAR PAIN AND ASSOCIATED DISC HERNIATIONS, AS WELL METHAMPHETAMINE IVDU. FOLLOWING WORK-UP, PLAN WAS MADE TO TRANSFER FOR FURTHER EVALUATION OF PAIN AND DETERMINE IF INFECTIOUS ETIOLOGY VS DEGENERATIVE CHANGES WITH RADICULOPATHY. PRIOR TO TRANSFER, COVID TESTING WAS ORDERED. RN PERFORMED COVID 19 NASOPHARYNGEAL SWAB IN LEFT NOSTRIL. THE SWAB BROKE 4.5CM FROM RED LINE WHERE SWAB NARROWS. THE PT IMMEDIATELY SNIFFED AND SWAB DISAPPEARED INTO NARE. THE ED MD WAS NOTIFIED IMMEDIATELY. THE PT BLEW HIS NOSE, WITH NO RETURN OF THE SWAB. A NASAL SPECULUM WAS USED IN ATTEMPT TO LOCATE AND WAS UNABLE TO LOCATE/VISUALIZE THE SWAB. X-RAY COMPLETED WITH NO VISUALIZATION. ENT WAS CONSULTED AND RECOMMENDED AFRIN ADMINISTRATION. TREATMENT INITIATED WITHOUT RETRIEVAL OF THE SWAB. THE PATIENT DEMONSTRATED NO RESPIRATORY DISTRESS - HIS ONLY COMPLAINT WAS CONGESTION. THE PATIENT WAS TRANSFERRED FOR FURTHER EVALUATION OF THE LOW BACK PAIN, WITH PLAN FOR ENT TO EVALUATE PATIENT. NASAL ENDOSCOPY WAS PERFORMED THE FOLLOWING DAY AFTER ADMINISTRATION OF LIDOCAINE/PHENYL

  Patient problems: Foreign Body In Patient

  MAUDE report 10527436 ↗

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