MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-02-15 for COMPOUND BENZOIN TINCTURE C1544 manufactured by 3m Health Care.
[1319502]
Patient (who is a nurse) reported developing 2 big blisters and many, raised, red, smaller blister covering the entire area under the strips and beyond, following wrist surgery. Compound benzoin tincture was used with the steri-strips. Patient was treated with silvadene and 2 doses of levaquin.
Patient Sequence No: 1, Text Type: D, B5
[8515633]
Product labeling states the expected aes with product use in the warning and contraindication sections shown below. Contraindications: steri-strip compound benzoin tincture should not be used on patients with a previous history of compound benzoin tincture. Warnings: allergic contact dermatitis to compound benzoin tincture has been reported. Flammable. For external use only.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2010-00018 |
| MDR Report Key | 1612561 |
| Report Source | 05 |
| Date Received | 2010-02-15 |
| Date of Report | 2010-02-10 |
| Date of Event | 2010-02-09 |
| Date Mfgr Received | 2010-02-10 |
| Date Added to Maude | 2010-02-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN RITTLE, MANAGER |
| Manufacturer Street | 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517330074 |
| Manufacturer G1 | 3M HEALTH CARE PLANT-BROOKINGS |
| Manufacturer City | BROOKINGS SD |
| Manufacturer Country | US |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPOUND BENZOIN TINCTURE |
| Generic Name | NA |
| Product Code | KOY |
| Date Received | 2010-02-15 |
| Catalog Number | C1544 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-02-15 |