MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-18 for CANNULA CURETTE 8MM LONG MX508 manufactured by Coopersurgical, Inc..
[15118240]
Hospital reported excessive bleeding occurred during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[15336144]
Coopersurgical inc is currently investigating the stated complaint. The device involved in the complaint has not been retuned by the customer for evaluation. Once all information is received from the customer and the investigation has been completed a follow-up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2014-00004 |
| MDR Report Key | 3705618 |
| Report Source | 06 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-03-14 |
| Date of Event | 2014-02-20 |
| Date Mfgr Received | 2014-02-20 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-04-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANA BANAFO |
| Manufacturer Street | 75 CORP DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CANNULA CURETTE 8MM LONG |
| Generic Name | CANNULA CURETTE |
| Product Code | HFC |
| Date Received | 2014-03-18 |
| Model Number | MX508 |
| Lot Number | 144853 |
| Device Expiration Date | 2016-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-18 |