MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-06-25 for QIAGEN 5126-1220 manufactured by Coopersurgical, Inc..
[1263387]
During a cervical sample, the brush head separated from the handle. The brush head was removed manually (fingers or forceps).
Patient Sequence No: 1, Text Type: D, B5
[8381063]
A review of the complaint database was conducted with no similarly reported complaints for this product. A dhr review was conducted on the 2 brush lots used in lot 71504 with no anomalies or deviations noted. Torque tests data were reviewed with acceptable results. A dhr review was conducted on lot 71504 with no deviation or anomalies noted. (b)(4). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2009-00017 |
| MDR Report Key | 1474767 |
| Report Source | 99 |
| Date Received | 2009-06-25 |
| Date of Report | 2009-06-25 |
| Date of Event | 2009-05-27 |
| Date Mfgr Received | 2009-05-28 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2010-06-03 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QIAGEN |
| Generic Name | DNA COLLECTION DEVICE |
| Product Code | HFE |
| Date Received | 2009-06-25 |
| Model Number | 5126-1220 |
| Lot Number | 71504 |
| Device Expiration Date | 2011-11-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-25 |