MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-15 for MITYVAC M-STYLE CUP 10007LP manufactured by Coopersurgical, Inc..
[139082049]
Coopersurgical, inc. Is currently investigating the reported condition. Once the investigation is complete, a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139082050]
I would like to report that the cup was ruptured during vacuum delivery operation. The device was changed to the new one, then procedure was completed. Baby had a abrasion on head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2019-00130 |
| MDR Report Key | 8424990 |
| Date Received | 2019-03-15 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-03-07 |
| Device Manufacturer Date | 2017-11-30 |
| Date Added to Maude | 2019-03-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETER NIZIOLEK |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 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 | MITYVAC M-STYLE CUP |
| Generic Name | MITYVAC M-STYLE CUP |
| Product Code | HDB |
| Date Received | 2019-03-15 |
| Model Number | 10007LP |
| Catalog Number | 10007LP |
| Lot Number | 236058 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-15 |