MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-10 for MALLINCKRODT 5-18437 manufactured by Mmj Sa De Cv(usd).
[107863630]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[107863631]
According to the reporter, the device's main balloon had pin hole. The customer had no reported patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2018-00334 |
| MDR Report Key | 7502814 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-10 |
| Date of Report | 2018-05-10 |
| Date Mfgr Received | 2018-05-02 |
| Device Manufacturer Date | 2017-03-31 |
| Date Added to Maude | 2018-05-10 |
| 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 | AVI KLUGER |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MMJ SA DE CV(USD) |
| Manufacturer Street | AVE HENEQUEN NO 1181 DESARROL |
| Manufacturer City | CIUDAD JUAREZ,MX 32590 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALLINCKRODT |
| Generic Name | AIRWAY, ESOPHAGEAL (OBTURATOR) |
| Product Code | CAO |
| Date Received | 2018-05-10 |
| Model Number | 5-18437 |
| Catalog Number | 5-18437 |
| Lot Number | 17C0861JZX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MMJ SA DE CV(USD) |
| Manufacturer Address | AVE HENEQUEN NO 1181 DESARROL CIUDAD JUAREZ,MX 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-10 |