MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-23 for SURG PATXRAY 3/4X3/4-200 801401 manufactured by Raynham.
[142795842]
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
[142795843]
It was reported that the doctor was using the pattie in a neuro/spine case to suction up blood. The pattie disintegrated while the doctor was pulling it out of the patient. The doctor had to go back in to collect all the small pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2019-00101 |
| MDR Report Key | 8541010 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-06-26 |
| Device Manufacturer Date | 2018-08-30 |
| Date Added to Maude | 2019-04-23 |
| 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 PATXRAY 3/4X3/4-200 |
| Generic Name | SURGICAL PATTIES |
| Product Code | HBA |
| Date Received | 2019-04-23 |
| Catalog Number | 801401 |
| Lot Number | J0032U |
| 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 | 2019-04-23 |