MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-10-14 for HC2 DNA COLLECTION DEVICE 5126-1220 manufactured by Digene Corp..
[450553]
Physician's office reproted that the cervical brush head became detached from its plastic handle during use. Physician removed the brush. No harm occurred and no additional treatment or medical intervention was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2005-00001 |
| MDR Report Key | 696606 |
| Report Source | 05,06 |
| Date Received | 2005-10-14 |
| Date of Report | 2005-10-14 |
| Date of Event | 2005-09-22 |
| Date Mfgr Received | 2005-09-23 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2006-04-10 |
| 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 | DONNA SOWERS |
| Manufacturer Street | 1201 CLOPPER ROAD |
| Manufacturer City | GAITHERSBURG MD 20878 |
| Manufacturer Country | US |
| Manufacturer Postal | 20878 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HC2 DNA COLLECTION DEVICE |
| Generic Name | CERVICAL BRUSH W/SPECIMEN COLLECTION MEDIUM |
| Product Code | HHT |
| Date Received | 2005-10-14 |
| Returned To Mfg | 2005-10-04 |
| Model Number | NA |
| Catalog Number | 5126-1220 |
| Lot Number | 189 |
| ID Number | NA |
| Device Expiration Date | 2008-06-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 685714 |
| Manufacturer | DIGENE CORP. |
| Manufacturer Address | * GAITHERSBURG MD * US |
| Baseline Brand Name | HC2 DNA COLLECTION DEVICE |
| Baseline Generic Name | CERVICAL BRUSH WITH STM |
| Baseline Model No | NA |
| Baseline Catalog No | 5126-1220 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K971586 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-10-14 |