MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-03-22 for SURG PAT XRAY 1X3 -200 801408 manufactured by Raynham.
[139574663]
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
[139574664]
It was reported by the ous affiliate on (b)(6) 2019, that after un-packaging the device, the physician found that the patties inside was contaminated (seemed like moldy). The physician changed with another of the same device. The event occurred during the used on patient; and there was 1 hour delay and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2019-00003 |
| MDR Report Key | 8444064 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-03-22 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-07-25 |
| Device Manufacturer Date | 2018-05-07 |
| Date Added to Maude | 2019-03-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 PAT XRAY 1X3 -200 |
| Generic Name | SURGICAL PATTIES |
| Product Code | HBA |
| Date Received | 2019-03-22 |
| Catalog Number | 801408 |
| Lot Number | HU3681 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2019-03-22 |