MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-14 for SURG PATXRAY 1/2X1/2-200 801400 manufactured by Raynham.
[145113769]
Attempts are being made to obtain additional information. Upon completion of the investigation, a follow-up report will be submitted
Patient Sequence No: 1, Text Type: N, H10
[145113770]
It was reported that the patties they have are not visible under fluoro. The patties came as part of this cardinal health surgical pack. They were concerned that there was a patty retained after surgery. They imaged the patient and did not see anything. They then imaged just a patty and did not see anything under fluoro and were concerned. They eventually found the patty and realized it was not retained in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2019-00145 |
| MDR Report Key | 8609818 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-10 |
| Date Mfgr Received | 2019-07-25 |
| Device Manufacturer Date | 2018-06-13 |
| Date Added to Maude | 2019-05-14 |
| 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 | USER KIMBERLY SHELLY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer G1 | RAYNHAM |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURG PATXRAY 1/2X1/2-200 |
| Generic Name | SURGICAL PATTIES |
| Product Code | HBA |
| Date Received | 2019-05-14 |
| Catalog Number | 801400 |
| Lot Number | HX1319 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAYNHAM |
| Manufacturer Address | 325 PARAMOUNT DRIVE 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |