MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-22 for OMNIPORE? SURGICAL IMPLANT OP9520 manufactured by Matrix Surgical Usa.
[139846389]
Labeling error identified prior to use. No patient involvement reported. Correction taken with recall (b)(4) reported to local regional fda office. Corrective action taken to improve manufacturing process and visibility of this type of labeling error will be reported in recall status reporting. Follow-up report will be submitted if additional information is available. Evaluation: photograph proved by customer with the compliant report confirms the right paranasal (op9520) is in a packaged labeled as op9519 (left).
Patient Sequence No: 1, Text Type: N, H10
[139846390]
This report initiated for the "poatienail" that the op9519 petite paranasal - right may be labeled as op9520 petite paranasal - right. On (b)(6) 2019, a physician reported to our (b)(4) distributor that a op9520 petite paranasal - right was labeled as a op9519 petite paranasal - left. The specific reported information from the distributor's email was: "our client claimed the implant (ref: op9519) was not labeled correctly. Op9519 shall be petite paranasal-left, however he found op9519 and op9520 were exact same for paranasal right while opened the sterilized packing".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009383407-2019-00003 |
| MDR Report Key | 8362666 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-22 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-01-29 |
| Device Manufacturer Date | 2017-01-06 |
| Date Added to Maude | 2019-02-22 |
| 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 | MS VICKI CLOUTIER |
| Manufacturer Street | 4025 WELCOME ALL ROAD SUITE 120 |
| Manufacturer City | ATLANTA GA 303491879 |
| Manufacturer Country | US |
| Manufacturer Postal | 303491879 |
| Manufacturer Phone | 9513260131 |
| Manufacturer G1 | MATRIX SURGICAL USA |
| Manufacturer Street | 4025 WELCOME ALL ROAD SUITE 120 |
| Manufacturer City | ATLANTA GA 303491879 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 303491879 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3009383407-01/30/2019 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIPORE? SURGICAL IMPLANT |
| Generic Name | OMNIPORE? SURGICAL IMPLANT - PETITE PARANASAL |
| Product Code | KKY |
| Date Received | 2019-02-22 |
| Model Number | OP9520 |
| Catalog Number | OP9520 |
| Lot Number | 022050617 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MATRIX SURGICAL USA |
| Manufacturer Address | 4025 WELCOME ALL ROAD SUITE 120 ATLANTA GA 303491879 US 303491879 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-22 |