MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-22 for IOBAN 1 manufactured by 3m Health Care.
[1381013]
Pt has shoulder surgery. Ioban was used. One post operative evening, pt complained of burning pain and blisters. Required 3 er visits and minor debridement and dressing changes. Dates of use: (b)(6)2010 - (b)(6)2010. Diagnosis or reason for use: surgical drape.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017212 |
| MDR Report Key | 1816183 |
| Date Received | 2010-08-22 |
| Date of Report | 2010-08-22 |
| Date of Event | 2010-03-12 |
| Date Added to Maude | 2010-09-02 |
| 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 |
| 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 |
| Brand Name | IOBAN 1 |
| Generic Name | SURGICAL PREP, 23IN X 17IN |
| Product Code | KOY |
| Date Received | 2010-08-22 |
| Lot Number | 34-8701-3139-7 |
| ID Number | CE 0086 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-08-22 |