MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-17 for MYSTIC II, BELL CUP 10058 manufactured by Coopersurgical Inc..
[142498951]
Coopersurgical inc. Is currently investigating the reported complaint condition. Reference e-complaint-(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[142498952]
Cooper surgical mitysoft bell cup vacuum. Item # 10058, lot # 223479. No patient injury. "the provider placed the vacuum on the fetal head, pumped the handle, no suction was available, pressure unattainable. The provider stated it was as if there was a leak in the vacuum. " ref e-complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2019-00054 |
| MDR Report Key | 8523503 |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-02-06 |
| Device Manufacturer Date | 2017-09-01 |
| Date Added to Maude | 2019-04-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. PETER NIZIOLEK |
| Manufacturer Street | 50 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MYSTIC II, BELL CUP |
| Generic Name | MYSTIC II, BELL CUP |
| Product Code | HDB |
| Date Received | 2019-04-17 |
| Model Number | 10058 |
| Catalog Number | 10058 |
| Lot Number | 223479 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL INC. |
| Manufacturer Address | CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-17 |