MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for KRONNER MANIPUJECTOR BOX 6003 manufactured by Coopersurgical, Inc..
[146048652]
(b)(4). Coopersurgical inc. Is currently investigating the reported complaint condition. Once the investigation is completed a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[146048653]
Received under medwatch mw5086410. Customer stated "the kronner uterine manipulator would not deflate. Md cut the inflation tip off to see if it would deflate, but it did not. Successfully removed and no pieces left behind, no injury to patient. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2019-00085 |
| MDR Report Key | 8633435 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-05-17 |
| Device Manufacturer Date | 2019-04-12 |
| Date Added to Maude | 2019-05-22 |
| 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 | 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 | KRONNER MANIPUJECTOR BOX |
| Generic Name | KRONNER MANIPUJECTOR |
| Product Code | KNA |
| Date Received | 2019-05-22 |
| Model Number | 6003 |
| Catalog Number | 6003 |
| Lot Number | 258155 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2019-05-22 |