FDA Adverse Event
Injury
Summary report: N
MERCURY MEDICAL
MDR report key: 1075378
·
Received July 9, 2008
Report
- Report Number
- 1024404-2008-00004
- Event Type
- Injury
- Date Received
- July 9, 2008
- Report Date
- July 7, 2008
- Product Code
- CAI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS NOT RETURNED; THEREFORE, MFR CAN NOT CONFIRM THAT IT IS MERCURY MEDICAL PRODUCT. MFR CAN NOT CONFIRM ALLERGIC REACTION WAS CAUSED BY THE PRODUCT. DEVICE HISTORY RECORDS FOR ALL MERCURY MEDICAL ANESTHESIA CIRCUITS (MAPLESON) PRODUCTS SOLD TO HOSP WERE REVIEWED AND FOUND TO BE MANUFACTURED TO SPECIFICATIONS. PRODUCT AND PACKAGING IS LATEX FREE.
Description of Event or Problem · 1
# 2 RN STAFF OPENED PACKAGE TO EXAMINE IT/FAMILIARIZE SELF WITH THE PRODUCT. WEIGHT UNK FEMALE AFTER OPENING AND HANDLING SHE BROKE OUT WITH A RASH, HOARSENESS AND VOMITING. SHE WAS TREATED IN THE ER WITH IV FLUIDS, ZOFRAN, PREDNISONE AND PEPCID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERCURY MEDICAL | ANESTHESIA CIRCUIT (MAPLESON) | CAI | 1080350 OR 1080351 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |