MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for 4416 manufactured by Covidien.
[71095415]
Submit date: 3/24/2017. An investigation is currently under way; upon completion the results will be forwarded. 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
[71095416]
It was reported to covidien on (b)(6) 2017 that a customer had an issue with surgical gauze. The customer states they received 7 gauze in the pack instead of 10.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611712-2017-05003 |
| MDR Report Key | 6432357 |
| Date Received | 2017-03-24 |
| Date of Report | 2018-02-26 |
| Date Mfgr Received | 2017-02-24 |
| Date Added to Maude | 2017-03-24 |
| 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 | COVIDIEN |
| Manufacturer Street | PADANG LATI, MUKIM PAYA |
| Manufacturer City | KANGAR 01700 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 01700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Product Code | EFQ |
| Date Received | 2017-03-24 |
| Model Number | 4416 |
| Catalog Number | 4416 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | PADANG LATI, MUKIM PAYA KANGAR 01700 MY 01700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-24 |