MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-23 for MASK, PROCEDURE, BLUE AT71021 manufactured by Cardinal Health 200 Llc.
[103323159]
The device history record could not be reviewed as the lot number was not available. As of this date, the sample has not been received, therefore the root cause could not be determined. If the sample is received, a follow up report will be filed. The complaint information was shared with the relevant sectors for their awareness. The mask ingredients were shared with shoreline allergy. This mask has been tested and met requirements for biological clearance for use. Testing was performed per fda memorandum (b)(4), aami/ansi/iso (b)(4) per fda recognition (b)(4) for cytotoxicity, irritation, and sensitization. There is no additional action taken at this time, but we will continue to monitor complaints for any trends.
Patient Sequence No: 1, Text Type: N, H10
[103323160]
Nurse sought treatment from shoreline allergy stating she had had an anaphylactic reaction to the mask. Shoreline allergy contacted cardinal health for mask ingredients. They state nurse is doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2018-00172 |
| MDR Report Key | 7365433 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-23 |
| Date of Report | 2018-03-23 |
| Date of Event | 2018-02-23 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-03-23 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | PATRICIA TUCKER |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer G1 | CARDINAL HEALTH 200 LLC |
| Manufacturer Street | 1 BUTTERFIELD TRAIL BLVD |
| Manufacturer City | EL PASO TX 79906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 79906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MASK, PROCEDURE, BLUE |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2018-03-23 |
| Catalog Number | AT71021 |
| Lot Number | UNKNOWN |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200 LLC |
| Manufacturer Address | 1 BUTTERFIELD TRAIL BLVD EL PASO TX 79906 US 79906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-23 |