MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-01-16 for DILATERIA THIN MX210 manufactured by Coopersurgical, Inc..
[19378270]
The mx210 (dilateria) was not returned to coopersurgical for evaluation. A query of our complaint database did not reveal any type of product trend for the dilateria breaking during insertion. Should this product be returned to coopersurgical at a later date, we will provide a device evaluation follow up to fda. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[19415857]
During laminaria insertion the mx210 (dilateria) broke inside the patient. Surgeon had to remove broken piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2012-00001 |
| MDR Report Key | 2435154 |
| Report Source | 05 |
| Date Received | 2012-01-16 |
| Date of Report | 2012-01-12 |
| Date of Event | 2011-12-30 |
| Date Mfgr Received | 2011-12-30 |
| Date Added to Maude | 2012-08-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE 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 | DILATERIA THIN |
| Generic Name | NONE |
| Product Code | HDY |
| Date Received | 2012-01-16 |
| Catalog Number | MX210 |
| Operator | HEALTH PROFESSIONAL |
| 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 | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-01-16 |