MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-29 for MYO/WIRE II KIT 040-397 manufactured by Alto Development Corporation.
[44012592]
Patient Sequence No: 1, Text Type: N, H10
[44012593]
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. Customer returned the entire lot minus 4 units that were reported to have been discarded because the seals were noted to be open.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242056-2016-00002 |
| MDR Report Key | 5619326 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-29 |
| Date of Report | 2016-04-29 |
| Date of Event | 2016-03-30 |
| Date Mfgr Received | 2016-03-30 |
| Device Manufacturer Date | 2016-01-04 |
| Date Added to Maude | 2016-04-29 |
| 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 KIT |
| Generic Name | DOUBLE WIRE STERNOTOMY SUTURE KIT |
| Product Code | GAO |
| Date Received | 2016-04-29 |
| Returned To Mfg | 2016-04-07 |
| Model Number | 040-397 |
| Catalog Number | 040-397 |
| Lot Number | 0575S |
| Operator | NURSE |
| Device Availability | R |
| 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 | 2016-04-29 |