MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-01 for DR FOG TREATED SPONGE, STERILE DF-3120 manufactured by Aspen Surgical Products, Caledonia.
[85112577]
The device is manually loaded into recessed pockets on the ffs machine, the likely root cause is operator error. Production has been notified of this defect and quality will continue to monitor. Device not returned, picture provided.
Patient Sequence No: 1, Text Type: N, H10
[85112578]
Packing failure: 2 pieces. Product in seal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2017-00083 |
| MDR Report Key | 6837986 |
| Date Received | 2017-09-01 |
| Date of Report | 2017-09-01 |
| Date of Event | 2017-06-16 |
| Date Mfgr Received | 2017-08-04 |
| Date Added to Maude | 2017-09-01 |
| 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 | MRS. MEGAN MORRISSEY |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer G1 | SAME AS ABOVE |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DR FOG TREATED SPONGE, STERILE |
| Generic Name | ANTI-FOG |
| Product Code | OCT |
| Date Received | 2017-09-01 |
| Model Number | DF-3120 |
| Lot Number | 123501 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, CALEDONIA |
| Manufacturer Address | 6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-01 |