MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-16 for SYMBOTEX COMPOSITE MESH/20*15 CM, BOX OF 1 SYM2015 manufactured by Sofradim Production.
[67597195]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[67597196]
According to the reporter: during the placement of the mesh on the patient, the surgeon observed that they were left small pieces of collagen in the glove. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615742-2017-00023 |
| MDR Report Key | 6335415 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-16 |
| Date of Report | 2017-01-24 |
| Date Mfgr Received | 2017-01-24 |
| Date Added to Maude | 2017-02-16 |
| 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 | SHARON MURPHY |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer G1 | SOFRADIM PRODUCTION |
| Manufacturer Street | 116 AVENUE DU FORMANS |
| Manufacturer City | TREVOUX |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMBOTEX COMPOSITE MESH/20*15 CM, BOX OF 1 |
| Generic Name | MESH, SURGICAL, NON-ABSORBABLE, LARGE ABDOMINAL WALL DEFECTS |
| Product Code | OXJ |
| Date Received | 2017-02-16 |
| Model Number | SYM2015 |
| Catalog Number | SYM2015 |
| Lot Number | PQC0574X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOFRADIM PRODUCTION |
| Manufacturer Address | 116 AVENUE DU FORMANS TREVOUX FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-16 |