MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-05-10 for MALLINCKRODT 5-18437 manufactured by Mmj, S.a. De C.v..
[107887026]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[107887027]
According to the reporter, when the unit was taken out of the box and inflated, the main balloon was noted to leak and had a small hole in it.
Patient Sequence No: 1, Text Type: D, B5
[132427657]
Evaluation summary: one sample was received for evaluation. The failure tear in cuff was confirmed in the received sample. Device history record was not reviewed since the lot number was not provided. Manufacturing process was reviewed and currently, there is not any potential risk and the below condition was found. Describe the guidelines to have a resting time of 4 hours with inflated cuffs and then the parts are inspected for proper inflated cuffs. All manufacturing controls were found acceptable and effective to detect the reported failure mode. Information has been added to the database and trends will continue to be monitored. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[132427658]
According to the reporter, when the unit was taken out of the box and inflated, the main balloon was noted to leak and had a small hole in it. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2018-00336 |
| MDR Report Key | 7503496 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-10 |
| Date of Report | 2018-10-18 |
| Date Mfgr Received | 2018-09-19 |
| 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 | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER,CO MA 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MMJ, S.A. DE C.V. |
| Manufacturer Street | AVE. HENEQUEN NO 1181 DESARROL |
| Manufacturer City | CIUDAD JUAREZ,CI 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 |
| Returned To Mfg | 2018-08-15 |
| Model Number | 5-18437 |
| Catalog Number | 5-18437 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MMJ, S.A. DE C.V. |
| Manufacturer Address | AVE. HENEQUEN NO 1181 DESARROL CIUDAD JUAREZ,CI 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-10 |