MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-28 for STERILE 3.5 SOFT KOH-EFF AD750SC-KE35 manufactured by Coopersurgical, Inc..
[128874771]
Coopersurgical, inc. Is currently investigating the reported complaint condition. Once the investigation is completed a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128874772]
Customer states on (b)(6) 2018 their was melting of koh soft cup during colpotomy. Doctor was able to remove all pieces from the patient nothing was left in the patient. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00077 |
| MDR Report Key | 8110225 |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-11-04 |
| Date Mfgr Received | 2018-11-12 |
| Device Manufacturer Date | 2018-09-10 |
| Date Added to Maude | 2018-11-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | STERILE 3.5 SOFT KOH-EFF |
| Generic Name | STERILE 3.5 SOFT KOH-EFF |
| Product Code | HEW |
| Date Received | 2018-11-28 |
| Model Number | AD750SC-KE35 |
| Catalog Number | AD750SC-KE35 |
| Lot Number | 227-18 |
| 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 | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-28 |