FDA Adverse Event
Other
Summary report: N
DISOPA SOLUTION
MDR report key: 538780
·
Received August 13, 2004
Report
- Report Number
- 2084725-2004-00059
- Event Type
- Other
- Date Received
- August 13, 2004
- Date of Event
- July 25, 2003
- Manufacturer
- JOHNSON & JOHNSON INC.
- Product Code
- MED
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
PT HAD AN ANAPHYLACTIC REACTION AFTER UNDERGOING A CYSTOSCOPY PROCEDURE WITH A SCOPE THAT HAD BEEN DISINFECTED IN DISOPA SOLUTION. UPON REMOVAL OF THE SCOPE THE PT EXPERIENCED HIVES ON FACE AND ARMS, ANAPHYLACTIC SHOCK. URTICARIA OF FACE AND ARMS AND HYPOTENSIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISOPA SOLUTION | DISINFECTANT | MED | JOHNSON & JOHNSON INC. | 17800 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other | 3. MITOMYCIN C, 4. CYTARABINE.| 1. INVERT SOAP, 2. LIDOCAINE CHLORIDE |