MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-12-07 for DIGENE A0040 * manufactured by Coopersurgical, Inc..
[414484]
During a routine pap sampling, the brush tip separated from the handle remaining in the patient's cervix. The physician located and removed the brush section without injury. There was no add'l medical attention required.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1216677-2005-00030 |
MDR Report Key | 651419 |
Report Source | 06 |
Date Received | 2005-12-07 |
Date of Report | 2005-12-06 |
Date Added to Maude | 2005-12-13 |
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 | TRUMBULL 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 | DIGENE |
Generic Name | BRUSH SAMPLER |
Product Code | GEE |
Date Received | 2005-12-07 |
Model Number | A0040 |
Catalog Number | * |
Lot Number | CB37Y |
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 | 640889 |
Manufacturer | COOPERSURGICAL, INC. |
Manufacturer Address | * TRUMBULL CT * US |
Baseline Brand Name | DIGENE |
Baseline Generic Name | BRUSH SAMPLER |
Baseline Model No | A0040 |
Baseline Catalog No | * |
Baseline ID | * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2005-12-07 |