MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-19 for BOUNDARY BOUFFANT CAPS REORDER# CRI1004 manufactured by Boundary Medical.
[17065004]
Pt being prepped for routine dental procedure, after a blue bouffant surgical cap was placed over pt's hair, a red splotchy, small bumps rash was noticed approx ten minutes after placement on pt's head; the rash followed the lines of the elastic band of the cap across the pt's forehead and temple areas of each side of the head; cheeks became pinkish red and pt developed same bumpy rash on the left side of neck and upper mid-chest area; rash was non-itchy and pt did not experience any tongue swelling or difficulty breathing; bouffant cap was removed immediately; and rash began to disappear immediately after removal of the cap. Dates of use: (b)(6) 2010. Diagnosis or reason for use: surgical attire during surgical procedure. Event abated after use stopped or dose reduced? Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018282 |
| MDR Report Key | 1908870 |
| Date Received | 2010-11-19 |
| Date of Report | 2010-11-19 |
| Date of Event | 2010-11-11 |
| Date Added to Maude | 2010-12-06 |
| 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 | RISK MANAGER |
| 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 | BOUNDARY BOUFFANT CAPS |
| Generic Name | SPUNBOND POLYPROPYLENE |
| Product Code | FYF |
| Date Received | 2010-11-19 |
| Model Number | NA |
| Catalog Number | REORDER# CRI1004 |
| Lot Number | 1004845919 |
| ID Number | BAR CODE# (01)30080196745771 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOUNDARY MEDICAL |
| Manufacturer Address | 4141 WESTMARK DR DUBUQUE IA 52002 US 52002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-11-19 |