MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2016-09-26 for DIGENE HC2 DNA COLLECTION DEVICE 619204 manufactured by Qiagen.
[55619739]
The device history record was reviewed and there were no irregularities noted during the manufacture of this lot. The actual device was not available for return. Remaining customer inventory was inspected and one additional device was found to be defective. An evaluation of this device was performed and concluded that the cause for the brush detachment was that it missed the heating process which aids in adhering the brush to the stem. Further investigation is pending. Device not available for return.
Patient Sequence No: 1, Text Type: N, H10
[55619740]
On (b)(6) 2016 (b)(6) received a report, (b)(6) from (b)(6) industrial health association in (b)(6) of an incident where the brush head became detached from the shaft and remained inside the patient. The brush was immediately removed from the patient without injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2016-00014 |
| MDR Report Key | 5976768 |
| Report Source | FOREIGN |
| Date Received | 2016-09-26 |
| Date of Report | 2016-09-26 |
| Date of Event | 2016-08-25 |
| Date Mfgr Received | 2016-08-26 |
| Device Manufacturer Date | 2015-10-21 |
| Date Added to Maude | 2016-09-26 |
| 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 | MS. DONNA SOWERS |
| Manufacturer Street | 19300 GERMANTOWN ROAD |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal | 20874 |
| Manufacturer Phone | 2406867876 |
| Manufacturer G1 | QIAGEN |
| Manufacturer Street | 19300 GERMANTOWN ROAD |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 20874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIGENE HC2 DNA COLLECTION DEVICE |
| Generic Name | DIGENE HC2 DNA COLLECTION DEVICE |
| Product Code | HHT |
| Date Received | 2016-09-26 |
| Catalog Number | 619204 |
| Lot Number | M1995 |
| Device Expiration Date | 2018-09-22 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QIAGEN |
| Manufacturer Address | 19300 GERMANTOWN ROAD GERMANTOWN MD 20874 US 20874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-26 |