MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for STERILE 3.5 ULTEM KOH-EFF AD750-KE35 manufactured by Coopersurgical, Inc..
[138778628]
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
[138778629]
Reported failure with one of the delineators during a case ((b)(6) 2019), the mechanism wouldn't slide on the device when attempting to insert it, and the shaft of the device lost its curve and was almost straight while attempting to insert.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2019-00125 |
| MDR Report Key | 8412690 |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-11-02 |
| Date Added to Maude | 2019-03-12 |
| 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 | STERILE 3.5 ULTEM KOH-EFF |
| Generic Name | STERILE 3.5 ULTEM KOH-EFF |
| Product Code | HEW |
| Date Received | 2019-03-12 |
| Returned To Mfg | 2019-03-27 |
| Model Number | AD750-KE35 |
| Catalog Number | AD750-KE35 |
| Lot Number | 274-18 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-12 |