| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SENSI-CARE BARRIER SPRAY | BANDAGE, LIQUID, SKIN PROTECTANT | CONVATEC LIMITED | NEC | 413502 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-12-18 | 0 | 1. L; 2. R |
Patient 1
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(6). (B)(4).
Patient 1
IT WAS REPORTED THE END USER APPLIED THE BARRIER SPRAY TO HER SKIN. A SHORT TIME LATER, THE END USER EXPERIENCED HER "THROAT CLOSING" AND PRESENTED TO THE EMERGENCY ROOM. AN EXAMINATION DETERMINED THE END USER HAD EXPERIENCED ANAPHYLAXIS AND SHE WAS TREATED WITH AN UNKNOWN STEROID. AT THE TIME OF THE INITIAL DIAGNOSIS, THE CAUSE OF THE END USER'S ANAPHYLAXIS WAS UNKNOWN. FOUR DAYS LATER, THE END USER APPLIED THE BARRIER SPRAY TO HER SKIN. AGAIN, THE END USER BEGAN TO SUFFER AN "ALLERGIC REACTION". HER SYMPTOMS ALLEGEDLY INCLUDED: BURNING EYES, ITCHY HANDS, HER THROAT "TIGHTENED", A WELT AT THE APPLICATION SITE AND HIVES OVER HER ENTIRE BODY. THE END USER TOOK AN OVER-THE-COUNTER ANTIHISTAMINE (BENADRYL) ORALLY AND AN UNSPECIFIED DOSE OF AN INHALED STEROID. THE INHALED STEROID USED WAS PREVIOUSLY PRESCRIBED FOR AN UNRELATED ASTHMATIC EVENT. HER SYMPTOMS IMPROVED THEREAFTER.