MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-08 for VERSALON ALL PURPOSE SPONGE 4X4IN 9025 manufactured by Covidien.
[141201123]
Additional information has been requested but at this time no additional details have been provided. The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Patient Sequence No: 1, Text Type: N, H10
[141201124]
The customer reports that they found a very fine, short, and white fibers on instruments and in the patient's eyes postoperative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018120-2019-00347 |
| MDR Report Key | 8491652 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-08 |
| Date of Report | 2019-06-18 |
| Date of Event | 2019-03-05 |
| Date Mfgr Received | 2019-03-25 |
| Date Added to Maude | 2019-04-08 |
| 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 | VERSALON ALL PURPOSE SPONGE 4X4IN |
| Generic Name | FIBER, MEDICAL, ABSORBENT |
| Product Code | FRL |
| Date Received | 2019-04-08 |
| Model Number | 9025 |
| Catalog Number | 9025 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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 | 2019-04-08 |