MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-16 for MYO/WIRE II 046-367 manufactured by Alto Development Corporation.
[47521445]
Device history record indicated that packaging was completed appropriately. No changes in personnel, equipment or process were identified. Records indicate that all appropriate seal checks were completed. Lot passed qc final inspection without issue. Complainant received 2 of 10 boxes in the complaint lot. There were no complaints from the other 5 customers who received product from the lot. All product was shipped in january and all but one of the 6 customers have reordered (including complainant) indicating that remaining product was used without an issue. Based on this, it is concluded that the one open unit was an isolated part. An internal capa has been opened to address manufacturing controls relative to the pouch sealing operation.
Patient Sequence No: 1, Text Type: N, H10
[47521446]
Customer returned product because they found the product pouch (sterile barrier) to be unsealed. No patient was involved, open seal was noted during preparation for procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242056-2016-00005 |
| MDR Report Key | 5729204 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-16 |
| Date of Report | 2016-06-16 |
| Date of Event | 2016-05-17 |
| Date Mfgr Received | 2016-05-23 |
| Device Manufacturer Date | 2015-11-30 |
| Date Added to Maude | 2016-06-16 |
| 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 ROD MACDONALD |
| Manufacturer Street | 5206 ASBURY ROAD |
| Manufacturer City | FARMINGDALE NJ 07727 |
| Manufacturer Country | US |
| Manufacturer Postal | 07727 |
| Manufacturer Phone | 7329382266 |
| Manufacturer G1 | ALTO DEVELOPMENT CORPORATION |
| Manufacturer Street | 5206 ASBURY ROAD |
| Manufacturer City | FARMINGDALE NJ 07727 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07727 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYO/WIRE II |
| Generic Name | DOUBLE WIRE STERNOTOMY SUTURE |
| Product Code | GAO |
| Date Received | 2016-06-16 |
| Model Number | 046-367 |
| Catalog Number | 046-367 |
| Lot Number | 0573S |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTO DEVELOPMENT CORPORATION |
| Manufacturer Address | 5206 ASBURY ROAD FARMINGDALE NJ 07727 US 07727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-16 |