MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for KOH CUPS 3.5CM.ULTEM (2) KCP-35-2 manufactured by Coopersurgical, Inc..
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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
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The cup was badly damaged after a single use seemed to be not as strong as the other cup in the package. States that they used the alternate cup and after first use it was in better shape than the first dr states he used the same settings while using both cups and one seemed to be extremely damaged after first use and the other held shape.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2019-00116 |
| MDR Report Key | 8394745 |
| Date Received | 2019-03-06 |
| Date of Report | 2019-03-06 |
| Date of Event | 2019-01-22 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2019-03-06 |
| 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 | KOH CUPS 3.5CM.ULTEM (2) |
| Generic Name | KOH CUPS 3.5CM.ULTEM (2) |
| Product Code | HEW |
| Date Received | 2019-03-06 |
| Returned To Mfg | 2019-02-05 |
| Model Number | KCP-35-2 |
| Catalog Number | KCP-35-2 |
| Lot Number | 228692 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-06 |