MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-12-13 for NEEDLE 3/8 CIRCLE REVERSE CUTTING, .037X1.535, STERILE 209012 manufactured by Aspen Surgical Products, Caledonia.
[130254199]
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.
Patient Sequence No: 1, Text Type: N, H10
[130254200]
Aspen surgical received a medwatch report (uf/imported report # (b)(4)) from the fda indicating that a 3/8 circle reverse cutting needle broke during a procedure. The incident occurred at the user facility. This report was filed in our complaint handling system as complaint #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2018-00128 |
| MDR Report Key | 8160895 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-12-13 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-11-16 |
| Date Added to Maude | 2018-12-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | NEEDLE 3/8 CIRCLE REVERSE CUTTING, .037X1.535, STERILE |
| Generic Name | SURGICAL NEEDLE |
| Product Code | GAB |
| Date Received | 2018-12-13 |
| Model Number | 209012 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other; 2. Required No Informationntervention | 2018-12-13 |