MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-15 for BINAXNOW 416-022 manufactured by Inverness Medical.
[1289753]
When collection a nasopharyngeal sample for the binaxnow influenza a&b test kit, the plastic shaft of the collection swab provided in the kit broke right where the foam and shaft meet. The plastic shaft and foam were lodged in the pt's nasal passage. The pt was referred to an ear, nose and throat (ent) specialist for removal of the swab tip. Per pt file, swab tip was successfully removed by the ent.
Patient Sequence No: 1, Text Type: D, B5
[8443986]
The nasopharyngeal swab is included as a component of the binaxnow influenza a & b test kit. The swab is a packaged component purchased from (b) (4). (b) (4) was contacted and informed of this adverse event. The sample was returned to (b) (4) manufacturer of the swab. For the evaluation and the results of the investigation of the reported swab, please reference mdr #1216735-2010-00001.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221359-2010-00001 |
| MDR Report Key | 1633014 |
| Report Source | 05 |
| Date Received | 2010-03-15 |
| Date of Report | 2010-03-12 |
| Date of Event | 2010-02-15 |
| Date Mfgr Received | 2010-02-17 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2010-03-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENNY FUCHS, DIRECTOR |
| Manufacturer Street | 10 SOUTHGATE RD |
| Manufacturer City | SCARBOROUGH ME 04074 |
| Manufacturer Country | US |
| Manufacturer Postal | 04074 |
| Manufacturer Phone | 2077305750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BINAXNOW |
| Generic Name | INFLUENZA A&B CLIA WAIVED 22 TEST KIT |
| Product Code | GNX |
| Date Received | 2010-03-15 |
| Catalog Number | 416-022 |
| Lot Number | 042447 |
| Device Expiration Date | 2011-10-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVERNESS MEDICAL |
| Manufacturer Address | SCARBOROUGH ME US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-15 |