MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for RICHARD ALLAN VESSEL LOOPS 3905 manufactured by Aspen Surgical Products, Inc..
[145222702]
Patient undergoes surgery for creation of left upper extremity arteriovenous (av) fistula. During procedure, mini red vessel loops were applied to artery and they broke in half. Manufacturer response for loop used in surgery for arteries and veins, richard-allan mini red vessel loops (per site reporter): device to be returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8615162 |
| MDR Report Key | 8615162 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-03-06 |
| Report Date | 2019-05-15 |
| Date Reported to FDA | 2019-05-15 |
| Date Reported to Mfgr | 2019-05-16 |
| Date Added to Maude | 2019-05-16 |
| 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 |
| Brand Name | RICHARD ALLAN VESSEL LOOPS |
| Generic Name | INSTRUMENT, SURGICAL, DISPOSABLE |
| Product Code | KDC |
| Date Received | 2019-05-16 |
| Catalog Number | 3905 |
| Lot Number | 177327 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, INC. |
| Manufacturer Address | 6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |