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 |