MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-01 for ALERE ISCREEN COT COTININE OFD TEST DCT-B702 manufactured by Alere San Diego, Inc..
[164799234]
Results pending investigation conclusion. Devices not returned. Product discarded/expended by customer.
Patient Sequence No: 1, Text Type: N, H10
[164799235]
(b)(6) 2019: patient experienced an allergic reaction to the sponge used with the alere iscreen cotinine oral fluid test. Patient was administered 25 mg of benedryl and the swelling subsided. Customer states patient seems to be fine after medication was administered. Although further information was requested, no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2019-00599 |
| MDR Report Key | 9267755 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-11-01 |
| Date of Report | 2019-11-01 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2019-10-23 |
| Date Added to Maude | 2019-11-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE RD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALERE ISCREEN COT COTININE OFD TEST |
| Generic Name | COTININE DRUG SCREEN |
| Product Code | MRS |
| Date Received | 2019-11-01 |
| Model Number | DCT-B702 |
| Lot Number | COT9040007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE RD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-01 |