MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-10-03 for MYO WIRE II - A&E MEDICAL N/A 040-365 manufactured by A&e Medical Corporation.
[122629199]
Final complaint information is pending. Return of packaged devices is pending.
Patient Sequence No: 1, Text Type: N, H10
[122629200]
Received notification of complaint from device technologies australia (distributor) on (b)(6) 2018 indicating packages of part number 040-365, lot number 0624s (sternotomy suture) were not sealed on one end. (2 boxes). These two boxes containing the unsealed packages were reported by (b)(6). A subsequent communication from device technologies on (b)(6) 2018 indicates the customer ((b)(6)) returned product to device technologies that was not aligned to what was initially reported. Device technologies is working with metro north hospital and health services to reconcile and will report the result to a&e medical. This may result in an adjustment to the initial complaint information. Due to this pending information this report will be preliminary. A follow-up (final) report will be executed once the information is received and the returned product is received by a&e medical and complaint is fully investigated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242056-2018-00002 |
| MDR Report Key | 7930946 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-10-03 |
| Date of Report | 2018-12-05 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2018-08-20 |
| Device Manufacturer Date | 2018-03-01 |
| Date Added to Maude | 2018-10-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR BILL KILBY |
| Manufacturer Street | 5206 ASBURY RD. |
| Manufacturer City | FARMINGDALE NJ 07727 |
| Manufacturer Country | US |
| Manufacturer Postal | 07727 |
| Manufacturer Phone | 7329382266 |
| Manufacturer G1 | A&E MEDICAL CORPORATION |
| Manufacturer Street | 5206 ASBURY RD. |
| 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 - A&E MEDICAL |
| Generic Name | STERNOTOMY SUTURE |
| Product Code | GAO |
| Date Received | 2018-10-03 |
| Returned To Mfg | 2018-11-02 |
| Model Number | N/A |
| Catalog Number | 040-365 |
| Lot Number | 0624S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A&E MEDICAL CORPORATION |
| Manufacturer Address | 5206 ASBURY RD. FARMINGDALE NJ 07727 US 07727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-03 |