MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-08-21 for manufactured by .
[25282974]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[37344261]
Corrective/preventive action plan: no corrective action is initiated at this point of time as the product conforms to the requirement and the allergy could be individual specific. Conclusion: we have also logged this complaint into our database system and will closely monitor our product performance to meet the quality objectives.
Patient Sequence No: 1, Text Type: N, H10
[37344263]
The doctor had an allergic reaction to the gloves which resulted in needing to go to the emergency room. The doctor's left hand was swollen and had to take antibiotics for about a week. We have been unable to obtain any additional information regarding treatment after several attempts. Quantity returned: one dispenser.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041005-2015-00001 |
| MDR Report Key | 5060316 |
| Report Source | 08 |
| Date Received | 2015-08-21 |
| Date Mfgr Received | 2015-08-05 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2015-09-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARALA JAYARMAN |
| Manufacturer Street | LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI |
| Manufacturer City | SEPANG, SELANGOR DARUL EHSAN 43900 |
| Manufacturer Country | MY |
| Manufacturer Postal | 43900 |
| Manufacturer Phone | 87061486 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Product Code | LYY |
| Date Received | 2015-08-21 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-21 |