MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-14 for MEDLINE FOG INHIBITOR WITH SPONGE NONFB100 MD-1001 manufactured by Aspen Surgical Products, Caledonia.
[77738968]
Patient Sequence No: 1, Text Type: N, H10
[77738969]
We received a complaint in regards to item number nonfb100 with the lot 123297. The complaint was for? Foam sealed in perimeter of packaging?. The issue was confirmed as the rectangular foam pad had been sealed on the seal of the pouch
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2017-00054 |
| MDR Report Key | 6641577 |
| Date Received | 2017-06-14 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-05-16 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-06-14 |
| 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 | MR BRADLEY LISKE |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDLINE FOG INHIBITOR WITH SPONGE NONFB100 |
| Generic Name | DR FOG |
| Product Code | OCT |
| Date Received | 2017-06-14 |
| Model Number | MD-1001 |
| Lot Number | 123297 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-06-14 |