MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-30 for POP-UP PORE CLEANER UNK manufactured by Msr Imports, Inc..
[284990]
Add'l info received from mfr 12-4-02: they have been previously advised by the pt of the issue regarding the pore cleaner. They do believe this incident was a result of misuse of the product but have since stopped selling this item. There is no further merchanidse being sold by company. As advised by the pt at the time they had recieved bruising which had disappeared after few days. They had never heard of this kind of incident in the past. Since this item has been discontinued they do not currently have any literature or samples available per request.
Patient Sequence No: 1, Text Type: D, B5
[21378563]
Consumer was using the cordless pore cleaner on their face for 3 mins. Consumer stated that they used cleaner for 10 secs on each area covering the left side of face, when they suddenly noticed a reddening and bruising of skin. Consumer turned the cleaner to the "off" position and discontinued its use. The next day consumer noticed that the reddening and bruising of the skin on the left side of their face was still present. Consumer immediately called dr and spoke to dr's office receptionist and explained incident. Receptionist scheduled an appointment for consumer to be seen by dr. Consumer called dealer and spoke to dealer's rep and explained incident. Rep instructed consumer to submit a written claim, explaining the incident and forward it to mfr's claims svc rep. Consumer faxed incident claim to mfr's claim svc rep. Consumer called importer and left message. Consumer received return call from importer's rep. Rep offered to reimburse consumer's medical cost. Rep referred consumer to importer's insurance agent. Consumer called importer's insurance co. Insurance agent rep took consumer's incident report and stated that the "general accident" insurance co would give the consumer a return call regarding consumer's incident claim. Consuemr visited dr. Dr determined that consumer's facial bruises and redness would probably heal in time. No rx consumer returned home. Consumer feels that the portable pore cleaner is unsafe and poses a personal injury hazard. Warning listed: "do not stay at one particular spot for more than 30 secs. In case of suction cup, it should not be used more than 10 secs".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003174 |
| MDR Report Key | 372817 |
| Date Received | 2001-11-30 |
| Date of Report | 2001-11-30 |
| Date of Event | 2001-11-26 |
| Date Added to Maude | 2002-01-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POP-UP PORE CLEANER |
| Generic Name | PORTABLE CORDLESS FACIAL PORE CLEANER |
| Product Code | GFE |
| Date Received | 2001-11-30 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 361924 |
| Manufacturer | MSR IMPORTS, INC. |
| Manufacturer Address | UNK PENNSAUKEN NJ 08109 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-11-30 |