MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-12 for SHILEY 313880 manufactured by Mallinckrodt Medical.
[102183470]
This product is not sold in us and is 510(k) exempt. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[102183471]
According to the reporter, during use, the device's balloon had water and secretions inside. Also, it was reported that the suctioning port was detached from the tube after the insertion. The customer reported that the patient was re-intubated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020889-2018-00031 |
| MDR Report Key | 7332808 |
| Date Received | 2018-03-12 |
| Date of Report | 2018-03-13 |
| Date of Event | 2018-02-20 |
| Date Mfgr Received | 2018-02-20 |
| Device Manufacturer Date | 2017-08-28 |
| Date Added to Maude | 2018-03-12 |
| 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 | AVI KLUGER |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MALLINCKRODT MEDICAL |
| Manufacturer Street | CORNAMADDY |
| Manufacturer City | ATHLONE 3810 |
| Manufacturer Postal Code | 3810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SHILEY |
| Product Code | BSK |
| Date Received | 2018-03-12 |
| Model Number | 313880 |
| Catalog Number | 313880 |
| Lot Number | 201707449X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALLINCKRODT MEDICAL |
| Manufacturer Address | CORNAMADDY ATHLONE 3810 3810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-12 |