MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-24 for PILLING manufactured by Teleflex Medical.
[134438275]
Mfr identified issues with the outer packaging of the products being improperly labeled. The product itself is properly labeled. Because of this, manufacturer recommends removing product containers out of service. However, our facility always immediately removes items from the container and verifies size on the device itself. And since the device itself is not an issue, and packaging is immediately discarded, no further action is needed at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083391 |
| MDR Report Key | 8277961 |
| Date Received | 2019-01-24 |
| Date of Report | 2019-01-22 |
| Date of Event | 2019-01-22 |
| Date Added to Maude | 2019-01-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PILLING |
| Generic Name | BOUGIE, ESOPHAGEAL, ENT |
| Product Code | KCD |
| Date Received | 2019-01-24 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-24 |