MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-18 for 90043170 DERMACEA X-RAY SPG 4X4 16 PLY 441601 manufactured by Covidien.
[40945795]
Submit date: (b)(6) 2016. An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[40945796]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a gauze sponge. The customer reports: there were (b)(4) gauze pads instead of (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[44586964]
A device history record review of the reported confirmed that the product was produced accomplishing quality requirements and released according to established procedures. There were no samples/photos received with this complaint therefore an examination of the reported condition could not be made. Through the investigation and analysis, the most possible root cause was identified as the worker mixed the rejected product from the weighing machine. As a continuous improvement, the supplier had updated their weighting system in (b)(6) 2015 and now weighs the product 2 times as opposed to previously being weighed only 1 time. Additionally, the operators were instructed to be more aware of the potential of a miscount during the weighing process. This complained lot was made prior to action taken. This complaint will be used for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2016-00074 |
| MDR Report Key | 5511445 |
| Date Received | 2016-03-18 |
| Date of Report | 2016-03-17 |
| Date Mfgr Received | 2016-05-02 |
| Date Added to Maude | 2016-03-18 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 90043170 DERMACEA X-RAY SPG 4X4 16 PLY |
| Generic Name | GAUZE SPONGE |
| Product Code | EFQ |
| Date Received | 2016-03-18 |
| Model Number | 441601 |
| Catalog Number | 441601 |
| Lot Number | 14042A |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-18 |