MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-01-09 for PAPARELLA-TYPE VENT TUBE, SILICONE .040" (6/PK) 240044 manufactured by Osta.
[64169537]
The device was not returned to olympus for evaluation. The exact cause of the reported event could not be determined; however, the most probable cause could be due to the patient? S pre-existing allergy. The instruction manual for use states,? Possible adverse effects. Known potential adverse reactions include: patient allergy or sensitivity to certain materials may result in tissue irritation.? As part of our investigation of this report, olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained.
Patient Sequence No: 1, Text Type: N, H10
[64169538]
Olympus was informed that during an unspecified procedure, a patient contracted a severe rash from the silicone vent tube that was placed inside the patient? S ear. The patient's current condition is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00010 |
| MDR Report Key | 6232853 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-09 |
| Date of Report | 2017-01-09 |
| Date of Event | 2016-10-25 |
| Date Mfgr Received | 2016-12-13 |
| Date Added to Maude | 2017-01-09 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAPARELLA-TYPE VENT TUBE, SILICONE .040" (6/PK) |
| Generic Name | PAPARELLA-TYPE VENT TUBE, SILICONE .040" (6/PK) |
| Product Code | ETD |
| Date Received | 2017-01-09 |
| Model Number | 240044 |
| Catalog Number | 240044 |
| Lot Number | MH593364 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTA |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-09 |