MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for 209504 manufactured by Aspen Surgical Products, Inc..
[181158322]
During surgery, tip of needle broke off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9763369 |
| MDR Report Key | 9763369 |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-05 |
| Report Date | 2020-02-21 |
| Date Reported to FDA | 2020-02-21 |
| Date Reported to Mfgr | 2020-02-27 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NEEDLE, SUTURING, DISPOSABLE |
| Product Code | GAB |
| Date Received | 2020-02-27 |
| Catalog Number | 209504 |
| Lot Number | 177096 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, INC. |
| Manufacturer Address | 6945 SOUTHBELT DRIVE S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |