MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-23 for 2ND SKIN BLISTER PADS manufactured by Medtrade Products Limited.
[703237]
Second skin blister pads was applied to patient's skin and removed the next day. A skin reaction took place exactly where adhesive made contact with skin. Pad left mark and is still "fade-ing" after one week. Dates of use: two days in 2007. Diagnosis or reason for use: blister. Event abated after use stopped or dose reduced? Yes. Event reappeared after reintroduction? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003559 |
| MDR Report Key | 904136 |
| Date Received | 2007-08-23 |
| Date of Report | 2007-08-23 |
| Date of Event | 2007-08-15 |
| Date Added to Maude | 2007-09-06 |
| 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 | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | 2ND SKIN BLISTER PADS |
| Product Code | FPX |
| Date Received | 2007-08-23 |
| Lot Number | 041244 |
| ID Number | 0-38472-50410 8 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 881651 |
| Manufacturer | MEDTRADE PRODUCTS LIMITED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-08-23 |