MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for MYSTIC 10057 manufactured by Coopersurgical, Inc..
[185707957]
A mushroom vacuum instrument broke during an instrument-assisted delivery. Details provided from delivery note: " a total of 3 pulls were performed, and 2 popoffs occurred. Two reapplications were performed. With the third pull, the mushroom vacuum handle broke, with cup left on the fetal head, which was removed. The fetal head had made some descent. After the vacuum broke, pushing continued with just maternal expulsive efforts with contractions. " no harm came to the patient or newborn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902792 |
| MDR Report Key | 9902792 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-02 |
| Report Date | 2020-02-26 |
| Date Reported to FDA | 2020-02-26 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYSTIC |
| Generic Name | EXTRACTOR, VACUUM, FETAL |
| Product Code | HDB |
| Date Received | 2020-03-31 |
| Model Number | 10057 |
| Lot Number | 271719 |
| Device Availability | * |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |