MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-03-16 for 3.3MM SRS POPLOK, SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE GKP-3301 manufactured by Conmed Corporation.
| Report Number | 1017294-2020-00094 |
| MDR Report Key | 9836870 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-16 |
| 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 | CONMED CORPORATION |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO, FL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.3MM SRS POPLOK, SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE |
| Generic Name | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
| Product Code | MBI |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-03-11 |
| Catalog Number | GKP-3301 |
| Lot Number | 1045454 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 11311 CONCEPT BLVD. LARGO, FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |