MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-15 for STERILE 3.5 ULTEM KOH-EFF AD750-KE35 manufactured by Coopersurgical, Inc..
[75323666]
Coopersurgical inc. Is currently investigating the reported complaint condition. Once the investigation is complaete a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75323667]
(b)(4). "while the surgeon was manipulating and applying cephelad pressure the delineator perforated through the uterus. The product was disposed immediately due to the malignancy cells in the uterus. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2017-00031 |
| MDR Report Key | 6566616 |
| Date Received | 2017-05-15 |
| Date of Report | 2017-07-18 |
| Date of Event | 2017-05-10 |
| Date Mfgr Received | 2017-05-12 |
| Device Manufacturer Date | 2017-05-01 |
| Date Added to Maude | 2017-05-15 |
| 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. NANA BANAFO |
| Manufacturer Street | 75 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 | STERILE 3.5 ULTEM KOH-EFF |
| Generic Name | STERILE 3.5 ULTEM KOH-EFF |
| Product Code | HEW |
| Date Received | 2017-05-15 |
| Model Number | AD750-KE35 |
| Catalog Number | AD750-KE35 |
| Lot Number | 105-17 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-05-15 |