MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-12-18 for SENSI-CARE BARRIER SPRAY 413502 manufactured by Convatec Limited.
[33869679]
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 Sequence No: 1, Text Type: N, H10
[33869680]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2015-00096 |
| MDR Report Key | 5310509 |
| Report Source | CONSUMER |
| Date Received | 2015-12-18 |
| Date of Report | 2015-12-03 |
| Date of Event | 2015-11-17 |
| Date Mfgr Received | 2015-12-03 |
| Date Added to Maude | 2015-12-18 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365244681 |
| Manufacturer G1 | CONVATEC, INC. |
| Manufacturer Street | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSI-CARE BARRIER SPRAY |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2015-12-18 |
| Model Number | 413502 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LIMITED |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH5 2NU UK CH5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2015-12-18 |