MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-02-28 for POTOCKY 6066 * manufactured by Coopersurgical, Inc..
[636373]
During a leep procedure, a potocky needle broke in the patient's cervix. The needle fragment was not found in the specimen, and it was later confirmed to be embedded in the patient's cervix. The attending physician has not yet decided if removal of the fragment is necessary.
Patient Sequence No: 1, Text Type: D, B5
[7870543]
As of the report date samples have not yet been received. Arrangements have been made to obtain the samples. Upon receipt, the samples will be evaluated. This report will be supplemented at the conclusion of this evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2007-00003 |
| MDR Report Key | 845334 |
| Report Source | 06 |
| Date Received | 2007-02-28 |
| Date of Report | 2007-02-28 |
| Date of Event | 2007-02-12 |
| Date Mfgr Received | 2007-02-13 |
| Date Added to Maude | 2007-05-09 |
| 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 | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR. |
| Manufacturer City | TRUBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POTOCKY |
| Generic Name | INTRA CERVICAL NEEDLE |
| Product Code | HEE |
| Date Received | 2007-02-28 |
| Model Number | 6066 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 832433 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | * TRUMBULL CT * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-02-28 |