MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-01-22 for ARGYLE 8888301515 manufactured by Mitg - Kenmex.
[97989951]
Submit date: 1/22/2018. An investigation is currently under way; upon completion the results will be forwarded. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[97989952]
The customer reports the sure grip was detached from tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2018-00008 |
| MDR Report Key | 7210882 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-01-22 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2018-01-05 |
| Date Added to Maude | 2018-01-22 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | MITG - KENMEX |
| Manufacturer Street | CALLE 9 SUR NO. 1113 CUIDAD |
| Manufacturer City | TIJUANA,NA 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGYLE |
| Generic Name | TUBING, NONINVASIVE |
| Product Code | GAZ |
| Date Received | 2018-01-22 |
| Returned To Mfg | 2018-03-02 |
| Model Number | 8888301515 |
| Catalog Number | 8888301515 |
| Lot Number | 1724815464 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MITG - KENMEX |
| Manufacturer Address | CALLE 9 SUR NO. 1113 CUIDAD TIJUANA,NA 22444 MX 22444 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-22 |