MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-08 for WEBCOL 6818 manufactured by Cardinal Health, Inc..
[144542121]
Multiple complaints have been received regarding alcohol prep pads being dry upon opening. The following are the dates, units, and magnitude of the complaints. A progressive care nurse noted using 3 prep pads on a single patient before the fourth pad have enough moisture to complete the job. Lot numbers were not noted. An orthopedic nurse noted dryness in alcohol prep pads over the course of 2-3 weeks. Lot numbers, again, were not recorded. Pre-op/pacu nurse noted dryness in alcohol prep pads over the course of multiple weeks. Manufacturer response for pad, alcohol, device disinfectant, webcol (per site reporter). The manufacturer was notified via purchasing department. Response is uncertain. Manufacturer response for pad, alcohol, device disinfectant, webcol (per site reporter). The manufacturer was notified via purchasing department. Response is uncertain. Manufacturer response for pad, alcohol, device disinfectant, webcol (per site reporter). The manufacturer was notified via purchasing department. Response is uncertain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8593691 |
| MDR Report Key | 8593691 |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-04-05 |
| Report Date | 2019-04-11 |
| Date Reported to FDA | 2019-04-11 |
| Date Reported to Mfgr | 2019-05-07 |
| Date Added to Maude | 2019-05-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WEBCOL |
| Generic Name | PAD, ALCOHOL, DEVICE DISINFECTANT |
| Product Code | LKB |
| Date Received | 2019-05-08 |
| Model Number | 6818 |
| Catalog Number | 6818 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH, INC. |
| Manufacturer Address | 7000 CARDINAL PLACE DUBLIN OH 43017 US 43017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-08 |