MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for MEDICAL ACTION INDUSTRIES 71133 manufactured by Medical Action Industries, Inc..
[135371922]
I used this item to prep the patients skin with and then noticed that he had scratches on his arm and 3 streaks where the skin was broken. The 3 scratches were up to 8 cm long and redness area was up to 14 cm long. The skin was broken and there was some blood, but a very scant amount. I called dr into the room for her to look at what happened. No photos were taken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8314547 |
| MDR Report Key | 8314547 |
| Date Received | 2019-02-07 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-12-31 |
| Report Date | 2019-01-02 |
| Date Reported to FDA | 2019-01-02 |
| Date Reported to Mfgr | 2019-02-07 |
| Date Added to Maude | 2019-02-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MEDICAL ACTION INDUSTRIES |
| Generic Name | I.V. START KIT |
| Product Code | LRS |
| Date Received | 2019-02-07 |
| Model Number | 71133 |
| Catalog Number | 71133 |
| Lot Number | 251204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES, INC. |
| Manufacturer Address | 25 HEYWOOD RD. ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-07 |