MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-10 for 3MM PIPET CURETTE BOX=50 MX140 manufactured by Coopersurgical Inc..
[123371838]
Coopersurgical inc. Is currently investigating the reported complaint condition. The device involved in the complaint has been returned by the customer for evaluation. Once the investigation is completed a follow-up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123371839]
"tip of curette broke off during procedure, took time and use of several instruments but was retrieved no injury to patient. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00051 |
| MDR Report Key | 7952094 |
| Date Received | 2018-10-10 |
| Date of Report | 2018-10-05 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2018-09-18 |
| Device Manufacturer Date | 2017-08-11 |
| Date Added to Maude | 2018-10-10 |
| 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 | 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 | 3MM PIPET CURETTE BOX=50 |
| Generic Name | 3MM PIPET CURETTE |
| Product Code | HHK |
| Date Received | 2018-10-10 |
| Model Number | MX140 |
| Catalog Number | MX140 |
| Lot Number | 224216 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL INC. |
| Manufacturer Address | CORPORATE DRIVE TRUMBULL 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-10-10 |