MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-01-25 for 2733 SPG GAUZE 4X4-16PLY manufactured by Covidien.
[134183572]
Samples were received for evaluation without the customer reporting an issue for this product. Several requests for additional information from the the customer was unsuccessful. Upon sample analysis on (b)(6) 2019 the product was found to be linting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018120-2019-00331 |
| MDR Report Key | 8278607 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-01-25 |
| Date of Report | 2019-02-12 |
| Date Mfgr Received | 2019-01-07 |
| Date Added to Maude | 2019-01-25 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524970 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1430 MARVIN GRIFFIN ROAD, PO B |
| Manufacturer City | AUGUSTA GA 30906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2733 SPG GAUZE 4X4-16PLY |
| Generic Name | FIBER, MEDICAL, ABSORBENT |
| Product Code | FRL |
| Date Received | 2019-01-25 |
| Returned To Mfg | 2018-12-21 |
| Model Number | 2733 |
| Catalog Number | 2733 |
| Lot Number | 18J093762 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1430 MARVIN GRIFFIN ROAD, PO B AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-25 |