MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-08 for BD? ALCOHOL SWABS 326910 manufactured by Bd Medical - Diabetes Care.
[116530295]
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[116530296]
It was reported that an allergic reaction of swollen lips and tongue occurred after chemicals were inhaled from the box of bd alcohol swabs. It was also reported that the consumer claims to be allergic to certain types of cardboard. There was no report of medical intervention noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920898-2018-00581 |
| MDR Report Key | 7765019 |
| Date Received | 2018-08-08 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-07-18 |
| Date Mfgr Received | 2018-07-19 |
| Device Manufacturer Date | 2018-02-20 |
| Date Added to Maude | 2018-08-08 |
| 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 | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BD MEDICAL - DIABETES CARE |
| Manufacturer Street | 1329 WEST HIGHWAY 6 |
| Manufacturer City | HOLDREGE NE 68949 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68949 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD? ALCOHOL SWABS |
| Generic Name | ALCOHOL CLEANSING WIPE |
| Product Code | LKB |
| Date Received | 2018-08-08 |
| Catalog Number | 326910 |
| Lot Number | 8051504 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL - DIABETES CARE |
| Manufacturer Address | 1329 WEST HIGHWAY 6 HOLDREGE NE 68949 US 68949 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-08 |