MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-04 for SURGIFOAM? SPONGE SIZE 12-7 PRODUCT CODE 1972 manufactured by Ferrosan Medical Devices A/s.
[188230860]
This report covers patient no. 4 out of 20. Please refer to fda report no. : 3008478369-2020-00001 (internal ferrosan medical devices a/s report no. : qn (b)(4)) for evaluation of this event. It was reported that similar events have occurred for around 20 patients over a year span. Therefore, 20 internal reports have been done and accordingly 20 reports to fda are done. Reference numbers: fda ferrosan medical devices a/s (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188230861]
This report covers patient no. 4 out of 20. Please refer to fda report no. : 3008478369-2020-00001 (internal ferrosan medical devices a/s report no. : qn (b)(4)) for evaluation of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008478369-2020-00005 |
| MDR Report Key | 9784625 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-04 |
| 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 | FERROSAN MEDICAL DEVICES A/S |
| Manufacturer Street | SYDMARKEN 5 |
| Manufacturer City | SOEBORG, 2860 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2860 |
| Manufacturer G1 | FERROSAN MEDICAL DEVICES A/S |
| Manufacturer Street | SYDMARKEN 5 |
| Manufacturer City | SOEBORG, 2860 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2860 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGIFOAM? SPONGE SIZE 12-7 PRODUCT CODE 1972 |
| Generic Name | SURGIFOAM? SPONGE |
| Product Code | LMF |
| Date Received | 2020-03-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FERROSAN MEDICAL DEVICES A/S |
| Manufacturer Address | SYDMARKEN 5 SOEBORG, 2860 DA 2860 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-04 |