MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for PDI NAIL POLISH REMOVER B71200 1102672 manufactured by Professional Disposables International, Inc..
[146054258]
Recently we made a process improvement team (pits) form out for defective nail polish remover pads being not effective. They were returned to supply chain and we received a new supply, which also deemed ineffective. We obtained new pads from every department in the hospital that had them, and all were ineffective at removing the polish. The policy states we need to have nail polish removed on affected extremity. The patient's husband left, bought a bottle of remover, and the polish promptly came off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8639785 |
| MDR Report Key | 8639785 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-05-17 |
| Report Date | 2019-05-20 |
| Date Reported to FDA | 2019-05-20 |
| Date Reported to Mfgr | 2019-05-24 |
| Date Added to Maude | 2019-05-24 |
| 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 | 3 |
| Brand Name | PDI NAIL POLISH REMOVER |
| Generic Name | PAD, ALCOHOL, DEVICE DISINFECTANT |
| Product Code | LKB |
| Date Received | 2019-05-24 |
| Model Number | B71200 |
| Catalog Number | 1102672 |
| Lot Number | 11400763 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. |
| Manufacturer Address | 2 NICE PAK PARK ORANGEBURG NY 10962 US 10962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-24 |