MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2016-03-24 for DIGENE HC2 DNA COLLECTION DEVICE 5122-1220 manufactured by Qiagen.
[41123120]
On (b)(6) 2015 incident reported to qiagen technical service. On (b)(4) 2015 incident date and details and defective device required. On (b)(4) 2015 customer reported the incident occurred. On (b)(6) 2015 and device was removed and discarded by physician same day. No other devices from the same box had this defect. On (b)(4) 2015 complaint history review found no prior complaints for this lot. On (b)(4) 2015 device history review found kit lot 170407 contained cervical brush (a0040) lots bscb41i and bscb42i. Both brush lots passed torque test qc specifications. On (b)(4) 2015 supplier notified of incident.
Patient Sequence No: 1, Text Type: N, H10
[41123121]
On (b)(6) 2015, qiagen received a report from (b)(6), (b)(4), where a brush head detached from the shaft while collecting sample from patient. The physician removed and discarded the device before reporting the incident to qiagen. In an abundance of caution, this incident is being reported now because a similar complaint for the same lot was reported (b)(4) that required medical intervention for removal although there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2016-00011 |
| MDR Report Key | 5525064 |
| Report Source | FOREIGN |
| Date Received | 2016-03-24 |
| Date of Report | 2016-03-24 |
| Date of Event | 2015-03-23 |
| Date Mfgr Received | 2015-03-27 |
| Device Manufacturer Date | 2014-10-06 |
| Date Added to Maude | 2016-03-24 |
| 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 | 2016-03-24 |
| Catalog Number | 5122-1220 |
| Lot Number | 170407 |
| Device Expiration Date | 2017-10-08 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-03-24 |