MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for ASPEN FLEXIBLE UNBANDED LIGHT HANDLE COVER, NON-STERILE LT-F05NS manufactured by Aspen Surgical Products, Caledonia.
[131771155]
Aspen surgical received a report from the distributor indicating that a flexible light handle cover was falling off of the lights having the potential to contaminate the sterile field. No injury/death was reported. No lot number or sample were provided for review. Cause not established. With no lot number or sample provided, no further information is available on the product at this time. However, if a sample becomes available and any additional relevant information is identified following evaluation, any additional relevant information will be submitted in a supplemental report. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[131771156]
Aspen surgical received a report from the distributor indicating that a flexible light handle cover was falling off of the lights. The item was in use. No injury/death was reported. This report was filed in our complaint handling system as number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2018-00130 |
| MDR Report Key | 8170527 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-11-16 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-12-17 |
| 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 UNBANDED LIGHT HANDLE COVER, NON-STERILE |
| Generic Name | LIGHT HANDLE |
| Product Code | FTA |
| Date Received | 2018-12-17 |
| Model Number | LT-F05NS |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-12-17 |