MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2014-05-29 for GAMMEX NON-LATEX PI ORTHO 20686565 manufactured by Ansell Lanka (pvt) Limited.
[17294566]
An mdr is being filed after user facility informed that the door, who has a known allergy to polyisoprene, developed a severe systemic allergic reaction after use of polyisoprene glove, gammex non-latex pi ortho. End user claimed that distributor sent the wrong replacement product.
Patient Sequence No: 1, Text Type: D, B5
[17622069]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1019632-2014-00009 |
MDR Report Key | 3879616 |
Report Source | 06,08 |
Date Received | 2014-05-29 |
Date of Report | 2014-05-29 |
Date of Event | 2014-05-28 |
Date Facility Aware | 2014-05-28 |
Report Date | 2014-05-29 |
Date Reported to FDA | 2014-05-29 |
Date Reported to Mfgr | 2014-05-29 |
Date Mfgr Received | 2014-05-28 |
Date Added to Maude | 2014-06-19 |
Event Key | 0 |
Report Source Code | Distributor report |
Manufacturer Link | N |
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 | TAMMY MCGRIFF |
Manufacturer Street | 1635 INDUSTRIAL RD. |
Manufacturer City | DOTHAN AL 36303 |
Manufacturer Country | US |
Manufacturer Postal | 36303 |
Manufacturer Phone | 3346152566 |
Manufacturer G1 | ANSELL LANKA (PVT) LIMITED |
Manufacturer Street | 1635 INDUSTRIAL RD. |
Manufacturer City | DOTHAN AL 36303 |
Manufacturer Country | US |
Manufacturer Postal Code | 36303 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | GAMMEX NON-LATEX PI ORTHO |
Generic Name | POWDER-FREE NON-NATURAL RUBBER LATEX |
Product Code | OPA |
Date Received | 2014-05-29 |
Catalog Number | 20686565 |
Lot Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ANSELL LANKA (PVT) LIMITED |
Manufacturer Address | BIYAGAMA CE |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2014-05-29 |