MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-02 for MALLINCKRODT 5-18541 manufactured by Mmj Sa De Cv (usd).
[74305643]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[74305884]
Medtronic received a communication regarding a combitube 41 fr tray. The customer reported that the cuff had breakage. The customer indicated there was no patient involvement with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2017-05170 |
| MDR Report Key | 6536039 |
| Date Received | 2017-05-02 |
| Date of Report | 2017-04-05 |
| Date of Event | 2017-04-05 |
| Date Mfgr Received | 2017-04-05 |
| Device Manufacturer Date | 2013-09-11 |
| Date Added to Maude | 2017-05-02 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | MMJ SA DE CV (USD) |
| Manufacturer Street | AVE HENEQUEN NO 1181 DESARROLL |
| Manufacturer City | CIUDAD JUAREZ 32590 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MALLINCKRODT |
| Generic Name | AIRWAY, ESOPHAGEAL (OBTURATOR) |
| Product Code | CAO |
| Date Received | 2017-05-02 |
| Model Number | 5-18541 |
| Catalog Number | 5-18541 |
| Lot Number | 13I0332JZX |
| Device Expiration Date | 2018-09-10 |
| 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 DESARROLL CIUDAD JUAREZ 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-02 |