MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-05-30 for 2X2 NONWOVEN DRESSING W/ PHMB 708999G manufactured by Covidien.
[146501996]
Additional information and the incident sample have been requested but to date have not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[146501997]
The customer reported the antimicrobial gauze pad stuck to her wound. There was no indication that further medical attention was needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018120-2019-00363 |
| MDR Report Key | 8654021 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date of Event | 2019-05-24 |
| Date Mfgr Received | 2019-05-24 |
| Date Added to Maude | 2019-05-30 |
| 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 | 5086183640 |
| 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 | 2X2 NONWOVEN DRESSING W/ PHMB |
| Generic Name | GAUZE/SPONGE, INTERNAL |
| Product Code | EFQ |
| Date Received | 2019-05-30 |
| Model Number | 708999G |
| Catalog Number | 708999G |
| Lot Number | 18G094262 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-05-30 |