MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-03 for DR FOG TREATED SPONGE, STERILE DF-3120 manufactured by Aspen Surgical Products, Caledonia.
[132569714]
No further information is available on the product at this time. The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[132569715]
Aspen surgical received a report from the distributor indicating that a dr fog sponge was discovered with a sealing issue. The item was not in use. No injury/death was reported. This report was filed in our complaint handling system under multiple lots as follows: (b)(4) - lot 166379 ((b)(4)); (b)(4) - lot 158682 ((b)(4)) ;(b)(4) - lot 164734 ((b)(4)).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2019-00002 |
| MDR Report Key | 8213702 |
| Date Received | 2019-01-03 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-11-07 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2019-01-03 |
| 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. JORDAN HACKERT |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer Phone | 6165367508 |
| 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 | 2019-01-03 |
| Model Number | DF-3120 |
| Lot Number | SEE ABOVE |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2019-01-03 |