MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-20 for DR FOG TREATED SPONGE, STERILE DF-3120 manufactured by Aspen Surgical Products, Caledonia.
[80757080]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[80757081]
Customer reported on (b)(6) that 2 pcs had a packing failure.
Patient Sequence No: 1, Text Type: D, B5
[120298343]
Operator error due to aspen's manual loading process of product into recessed pockets on the ffs machines by operators. Device not returned, picture provided.
Patient Sequence No: 1, Text Type: N, H10
[120298344]
Customer reported on (b)(6) 2015 that 2 pcs had a packing failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2017-00073 |
| MDR Report Key | 6730054 |
| Date Received | 2017-07-20 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2017-06-22 |
| Date Added to Maude | 2017-07-20 |
| 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 | 2017-07-20 |
| Model Number | DF-3120 |
| Lot Number | 124814 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-07-20 |