MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2016-05-13 for CAREBRUSH 619024 manufactured by Qiagen.
[45136139]
The device was being used in (b)(6) as part of a customer's study for self sample collection. The currently marketed intended use for carebrush is to be used by physicians and trained medical professionals for the collection of cervical specimens for subsequent testing of the (b)(6) test. Several attempts were made to follow up with the reporting facility to obtain further details around this incident. The reporting facility was unable to provide further details. Similar complaints have been reported for this brush. Prior investigation concluded that the device malfunction was due to the brush missing the heating process which adheres it to the stem. There have been a total of 5 complaints for detached brush tips reported since this device has been in distribution (1997). Over (b)(4) brushes have been distributed. (b)(4). This defect is not likely to cause an adverse event and the probability of this defect requiring medical or surgical intervention is remote. This product is not approved or distributed in the us, however the brush is substantially similar to the digene hc2 dna collection device that is approved in the us. Device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[45136140]
On 13apr2016 qiagen received a report, (b)(4), from (b)(6) of an incident where the brush head became detached from the shaft and remained inside the end user. The nursing assistant examined the end user and could not locate the brush. Two days later the end user returned to the health facility and informed them that the brush was expulsed and no injuries were incurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2016-00012 |
| MDR Report Key | 5652832 |
| Report Source | FOREIGN |
| Date Received | 2016-05-13 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-03-29 |
| Date Mfgr Received | 2016-04-13 |
| Date Added to Maude | 2016-05-13 |
| 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 | 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 | CAREBRUSH |
| Generic Name | CAREBRUSH |
| Product Code | HHT |
| Date Received | 2016-05-13 |
| Catalog Number | 619024 |
| Lot Number | UNKNOWN |
| 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 | 2016-05-13 |