MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2006-07-19 for UTERINE MANIPULATOR- 7CM UM201 manufactured by Ethicon Endo-surgery, Inc. (cincinnati).
[19244231]
It was reported that prior to an unk procedure, the balloon had been cut before using. Another device was used to complete the case. There were no adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5
[19342600]
Info anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1527736-2006-03426 |
| MDR Report Key | 740686 |
| Report Source | 01,07 |
| Date Received | 2006-07-19 |
| Date of Report | 2006-06-28 |
| Date of Event | 2006-06-26 |
| Date Mfgr Received | 2006-06-27 |
| Date Added to Maude | 2006-07-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | GARY LEBLANC |
| Manufacturer Street | 4545 CREEK RD |
| Manufacturer City | CINCINNATI OH 452422803 |
| Manufacturer Country | US |
| Manufacturer Postal | 452422803 |
| Manufacturer Phone | 5133378582 |
| Manufacturer G1 | CLINICAL INNOVATIONS |
| Manufacturer Street | 747 W 4170 S |
| Manufacturer City | MURRAY UT 84123136 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84123 1364 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UTERINE MANIPULATOR- 7CM |
| Generic Name | LKF |
| Product Code | LFK |
| Date Received | 2006-07-19 |
| Model Number | NA |
| Catalog Number | UM201 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 728554 |
| Manufacturer | ETHICON ENDO-SURGERY, INC. (CINCINNATI) |
| Manufacturer Address | * CINCINNATI OH * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-19 |