MityOne 10067Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888937003123), received between Jan 4, 2019 and Jun 25, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFANT SUSTAINED DIFFUSE SCALP HYPERDENSE SWELLING IN THE LEFT TEMPOROPARIETAL AND POSTERIOR PARIETO-OCCIPITAL REGION UPON BIRTH. THE MITYONE VACUUM SYSTEM WAS USED DURING DELIVERY. INITIAL DIAGNOSIS SO FAR IS THAT THERE NO ACUTE INFARCTS OR BRAIN HEMORRHAGE. INFANT WAS ADMITTED TO THE NICU. NO ADDITIONAL INFORMATION IS AVAILABLE. 100670 MITYONE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608482 ↗
• MalfunctionJul 25, 2021Break; Use of Device Problem

  REPORT SUBMITTED BY (B)(6) ON BEHALF OF END-USER- WE HAVE RECEIVE A CUSTOMER COMPLAINT WITH REGARD TO THE USE OF A MITYONE VAC DEVICE (LOT: 271732). THE CUSTOMER HAS REPORTED THE FOLLOWING: THE MITYONE WAS BEING USED FOR A BIRTH. IT WAS THE 4TH PULL OF THE VACUUM WHEN THE PRODUCT SNAPPED AT THE BASE OF THE CUP. THERE WAS NO LOSS OF SUCTION AT ANY POINT IN TIME PRIOR TO THIS AND THE SUCTION STRENGTH WAS IN THE GREEN ZONE ON THE PRODUCT. THE CUSTOMER HAS SINCE CONFIRMED THAT THE NEW BORN WAS NOT INJURED AS A RESULT OF THE INCIDENT. WE HAVE THE PRODUCT READY FOR RETURN TO COOPERSURGICAL FOR EVALUATION. MITYONE MUSHROOM CUP 10067 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222806 ↗
• MalfunctionMay 8, 2021Mechanical Problem

  REPORT SUBMITTED BY ARABIAN MEDICAL DEVICES LLC: WE HAVE RECEIVED AN INCIDENT REPORT AGAIN FROM ONE OF THE (B)(6) HOSPITAL ON OUR MITYONE VACUUM ASSISTED DELIVERY SYSTEM 10067. THE IMPORTANT POINTS ARE AS FOLLOWS: 1. FAULTY PRESSURE BUILDING MECHANISM. 2. INCREASED CEPHALHEMATOMA. FOLLOW-UP: 1. THE VACUUM RELEASES AUTOMATICALLY. 2. INCREASED CERVICAL & VAGINAL TEAR. 3. INCREASED NUMBER OF CEPHALHEMATOMA. 1216677-2021-00090-1 MITYONE MUSHROOM CUP 10067, E-COMPLAINT: (B)(4).

  Patient problems: Cephalohematoma; Vaginal Mucosa Damage

  MAUDE report 11795284 ↗
• MalfunctionFeb 17, 2021Material Separation

  REPORT STATED: "THE MITYONE PRODUCT FAILURE OCCURRED ON 1-08-21. 32 Y.O. PATIENT, SECOND PREGNANCY, FIRST ATTEMPTED VAGINAL DELIVERY. TWO SUCCESSFUL PULLS WITH THE MITYONE M-STYLE MUSHROOM CUP WITH FETAL HEAD TRAVEL. THIRD PULL RESULTED IN CUP FAILURE. THE M-STYLE MUSHROOM CUP SEPARATED FROM THE STEM. C-SECTION WAS SUCCESSFUL. MOTHER AND BABY ARE WELL (APGAR SCORE OF 9) AND NO ADDITIONAL MEDICAL ATTENTION WAS REQUIRED. 10067 MITYONE MUSHROOM CUP E-COMPLAINT (B)(4).

  Patient problems: Bruise/Contusion

  MAUDE report 11339676 ↗
• MalfunctionFeb 17, 2021Pressure Problem

  WE ARE RECEIVING MORE FEEDBACKS FROM END USERS IN (B)(6) HOSPITAL FOR THE ABOVE ITEM AS FOLLOWS: -THE PRESSURE IS NOT BUILDING UP DUE TO WHICH A SECOND CUP HAS TO BE OPENED IMMEDIATELY. THIS HAS OCCURRED MULTIPLE TIMES. -ACCORDING TO THE PEDIATRICIANS, SUB GALEAL HEMORRHAGES & FETAL DISTRESS EPISODES HAVE INCREASED. FOLLOW-UP: "FURTHER TO YOUR MAIL WE HAD A MEETING TODAY WITH THE END USERS OF (B)(6) HOSPITAL SULTANATE OF OMAN. UNFORTUNATELY, THEY DON'T KEEP ANY TRACK RECORD FOR THE FAILED VACUUM DELIVERIES AND SINCE THEY HAVE DISCARDED THE AFFECTED PIECES AFTER USE, WE ARE UNABLE TO SEND THE SAMPLES BACK TO YOUR FACILITY FOR THE FURTHER INVESTIGATIONS." 1216677-2021-00015-1 MITYONE MUSHROOM CUP 10067 (B)(4).

  Patient problems: Fetal Distress; Hemorrhage, Subgaleal

  MAUDE report 11336651 ↗
• MalfunctionDec 1, 2020Break

  REPORT STATED: "MD ATTEMPTING VACUUM. BOTH ITEMS BROKE AT THE JUNCTION WHERE THE MUSHROOM CAP MEETS THE LONG PLASTIC ARM". 10067 MITYONE MUSHROOM CUP (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 10927468 ↗
• MalfunctionNov 6, 2020Break

  CUSTOMER REPORTED: ""MD ATTEMPTING VACUUM. BOTH ITEMS BROKE AT THE JUNCTION WHERE THE MUSHROOM CAP MEETS THE LONG PLASTIC ARM". 1216677-2020-00255-1 10067 MITYONE MUSHROOM CUP (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 10803701 ↗
• MalfunctionOct 9, 2020Break

  CUSTOMER STATED: "WE HAD A MITYVAC MUSHROOM CUP FAIL DURING A DELIVERY OVERNIGHT. THE DEVICE BROKE APART WHERE THE SUCTION CUP AND STEM ARE CONNECTED AND THE SUCTION CUP REMAINED ON THE BABY'S HEAD AFTER IT BROKE. A NEW DEVICE WAS APPLIED AND THE DELIVERY WAS COMPLETED WITHOUT HARM TO THE BABY. THE PACKAGING WAS RETRIEVED, BUT UNFORTUNATELY THE DEVICE ITSELF WAS DISCARDED". 1216677-2020-00230-1 10067 MITYONE MUSHROOM CUP (B)(4)

  Patient problems: Insufficient Information

  MAUDE report 10656140 ↗
• MalfunctionSep 9, 2020Use of Device Problem

  REPORT SUBMITTED BY CSI REP ON BEHALF OF ACCOUNT - PRODUCT "DID NOT SEAL X2 ATTEMPTS". FORCEPS USED TO COMPLETE PROCEDURE. MITYONE MUSHROOM CUP 10067 E-COMPLAINT-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10507076 ↗
• MalfunctionJan 4, 2019Appropriate Device Problem Term/Code Not Available

  THE MUSHROOM CUP FAILED DURING A DELIVERY. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8219308 ↗