MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2019-12-10 for WAYNE PNEUMOTHORAX SET N/A C-UTPT-1400-WAYNE-IMH manufactured by Cook Inc.
[175846858]
Pma/510(k) #: exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[175846859]
It was reported that during inspection of a wayne pneumothorax set at a distribution facility in (b)(6), an unidentified particle was observed inside the primary packaging of the product. No patient contact was made and no other adverse effects have been reported for this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-03069 |
| MDR Report Key | 9444681 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2019-12-10 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-07-31 |
| Date Added to Maude | 2019-12-10 |
| 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 | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAYNE PNEUMOTHORAX SET |
| Generic Name | JOL CATHETER AND TIP, SUCTION |
| Product Code | JOL |
| Date Received | 2019-12-10 |
| Model Number | N/A |
| Catalog Number | C-UTPT-1400-WAYNE-IMH |
| Lot Number | NS9856121 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-10 |