MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-30 for SPECTRUM AUTOPASS SUTURE PASSER SMI-02AP manufactured by Classic Wire Cut Co, Inc..
| Report Number | 1017294-2020-00161 |
| MDR Report Key | 9899269 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2019-05-08 |
| Date Added to Maude | 2020-03-30 |
| 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. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 3995358 |
| Manufacturer G1 | CLASSIC WIRE CUT CO, INC. |
| Manufacturer Street | 28210 CONSTELLATION ROAD |
| Manufacturer City | VALENCIA, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRUM AUTOPASS SUTURE PASSER |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | LXH |
| Date Received | 2020-03-30 |
| Catalog Number | SMI-02AP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLASSIC WIRE CUT CO, INC. |
| Manufacturer Address | 28210 CONSTELLATION ROAD VALENCIA, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |