MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-07-13 for PREMIER UNK * manufactured by Premier Medical (mfg).
[17906988]
The tip of a teflon dilator broke off in a pt's uterus and was removed.
Patient Sequence No: 1, Text Type: D, B5
[20144096]
Company was advised that the tip of a teflon instrumetn broke off in a patient uterus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2521453-2001-00001 |
| MDR Report Key | 342330 |
| Report Source | 05 |
| Date Received | 2001-07-13 |
| Date of Report | 2001-07-13 |
| Date of Event | 2001-06-19 |
| Date Mfgr Received | 2001-06-19 |
| Date Added to Maude | 2001-07-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 10090 SANDMEYER LANE |
| Manufacturer City | PHILADELPHIA PA 19116 |
| Manufacturer Country | US |
| Manufacturer Postal | 19116 |
| Manufacturer Phone | 2156769090 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREMIER |
| Generic Name | UTERINE DILATOR |
| Product Code | HDQ |
| Date Received | 2001-07-13 |
| Model Number | UNK |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 331666 |
| Manufacturer | PREMIER MEDICAL (MFG) |
| Manufacturer Address | 10090 SANDMEYER LANE PHILADELPHIA PA 19116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-07-13 |