MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILE LT-F01B manufactured by Aspen Surgical Products, Caledonia.
[125656556]
Aspen surgical received a report from the distributor indicating that a flexible light handle cover was discovered with a potential seal issue. Samples were not available for evaluation. A review of the device history record was performed for the lot numbers. No non-conformance's were noted relating to the reported issue. Pouch material of the product is a breathable packaging material and would allow air to escape from inside the pouch. Due to no samples provided, no further information is available on the product at this time. No further actions required. Device not available.
Patient Sequence No: 1, Text Type: N, H10
[125656557]
Aspen surgical received a report from the distributor indicating that a flexible light handle cover was discovered with a potential seal issue. The item was not in use. No injury/death was reported. This report was filed in our complaint handling system for multiple lots as follows: (b)(4) - lot 142114. (b)(4) - lot 130570.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2018-00109 |
| MDR Report Key | 8019997 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-02 |
| Date Added to Maude | 2018-10-30 |
| 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 | ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILE |
| Generic Name | LIGHT HANDLE |
| Product Code | FTA |
| Date Received | 2018-10-30 |
| Model Number | LT-F01B |
| Lot Number | SEE ABOVE |
| 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 | 2018-10-30 |