MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-04-07 for INSTA GARD YELLOW ISOLATION MASK AT70061 manufactured by Cardinal Health.
[19911875]
A respiratory therapist developed a rash with severe itching. The rash looked similar to hives, and spread to her neck/chest/upper back/upper arms. She saw several physicians and received treatment and was given medications. Presently, she is not having any problems.
Patient Sequence No: 1, Text Type: D, B5
[19937540]
The lot number was not provided, therefore, the device history record could not be reviewed. No sample was provided. Without the lot number or the sample, we are unable to assign a root cause. During the product development phase, all materials used in this mask were evaluated for biocompatibility. The testing was performed in accordance with international standard ios 10993 biological evaluation of medical devices. Only materials that successfully complete these tests can be commercialized. The tests utilized are designed to predict the safety of the product for the general population of users. Unfortunately no test or series of tests can guarantee that a particular item will be compatible with all users. No changes have been made in the manufacturing process for this product that would account for this type of event. We will continue to monitor for complaints of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2010-00016 |
| MDR Report Key | 1653529 |
| Report Source | 05,07 |
| Date Received | 2010-04-07 |
| Date of Report | 2010-03-17 |
| Date of Event | 2010-02-05 |
| Date Mfgr Received | 2010-02-18 |
| Date Added to Maude | 2011-04-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSTA GARD YELLOW ISOLATION MASK |
| Generic Name | ISOLATION MASK |
| Product Code | LGM |
| Date Received | 2010-04-07 |
| Catalog Number | AT70061 |
| Lot Number | NO LOT GIVEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-07 |