MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-21 for DR FOG W/ BOTTLE, BULK STERILE DF-3100B manufactured by Aspen Surgical Products, Caledonia.
[88145914]
Customer reported on (b)(4) that during inspection they found damaged packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2017-00095 |
| MDR Report Key | 6882389 |
| Date Received | 2017-09-21 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-08-24 |
| Date Mfgr Received | 2017-08-24 |
| Date Added to Maude | 2017-09-21 |
| 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 W/ BOTTLE, BULK STERILE |
| Generic Name | ANTI-FOG |
| Product Code | OCT |
| Date Received | 2017-09-21 |
| Returned To Mfg | 2017-08-31 |
| Model Number | DF-3100B |
| Lot Number | 122664 |
| Device Availability | R |
| 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 | 2017-09-21 |