FDA Adverse Event
Injury
Summary report: N
GUTTA PERCHA
MDR report key: 194715
·
Received October 23, 1998
Report
- Report Number
- MW1014860
- Event Type
- Injury
- Date Received
- October 23, 1998
- Date of Event
- October 8, 1998
- Report Date
- October 19, 1998
- Manufacturer
- UNK
- Product Code
- EKM
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- KS, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
GUTTA PERCHA PLACED ON 10/8/98, INCREASED ASTHMA ON 10/9/98, PREVENTIL HFA, AROBIOM TILADE. GREATER INCREASED ASTHMA ON 10/10/98, PEAK FLOW 350 (NORMAL 600). ASTHMA, HIVES AT 2 AM ON 10/11/98, PEAK FLOW 350, PROVENTIL HFA, BENADRYL IM 50MG, PREDNISONE 20MG BY MOUTH. PREDNISONE TAPERING DOSES FROM 10/11-10/18/98: 60MG, 60MG, 40MG, 40MG, 20MG, 20MG, 10MG, 10MG. CONTINUED PROVENTIL HFA AS NEEDED. GUTTA PERCHA REMOVED ON 10/13/98. SINGNIFICANT EASING OF ASTHMA ON 10/15/98. NO SYMPTOMS ON 10/16/98.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUTTA PERCHA | GUTTA PERCHA | EKM | UNK | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Life Threatening |