MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-13 for 27G ANTERIOR CHAMBER-PACK 27AMO manufactured by Aspen Surgical Products, Caledonia.
[144831262]
Aspen surgical received a report from the distributor indicating that an anterior chamber cannula introduced a fiber into the patient during a procedure. Incident occurred at the end user. No sample or manufacturing lot number was provided for review. The customer reported during an eye procedure, a red cotton fiber was released from the eye cannula into the patient? S eye. The surgeon was able to successfully retrieve the fiber without incident. The patient was not harmed. The source of the fiber is not known. No manufacturing lot number was provided, therefore a review of the device history record could not be completed. Additionally, no sample was available for return. The complaint cannot be confirmed and an additional investigation cannot be performed. Product has been discontinued. Based on this information, no further action is required. Device evaluated by mfr: device not available.
Patient Sequence No: 1, Text Type: N, H10
[144831263]
Aspen surgical received a report from the distributor indicating that an anterior chamber cannula introduced a fiber into the patient during a procedure. Incident occurred at the end user. This report was filed in our complaint handling system as complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2019-00039 |
| MDR Report Key | 8603505 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-13 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-05-13 |
| 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 | 3 |
| Brand Name | 27G ANTERIOR CHAMBER-PACK |
| Generic Name | ANTERIOR CHAMBER CANNULA |
| Product Code | HMX |
| Date Received | 2019-05-13 |
| Model Number | 27AMO |
| 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 | 1. Other; 2. Required No Informationntervention | 2019-05-13 |