MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-03-13 for SURG PAT XRAY 1/2 X 3 80-1407 manufactured by Codman & Shurtleff, Inc..
[139724818]
Udi - (b)(4). Multiple attempts to obtain additional information were not successful. Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed. Applicable device history records (dhrs) were reviewed and no anomalies were found when j0560d was released to stock september 18th, 2018 and hx1397 was released to stock july 23rd, 2018. A review of manufacturing records found no discrepancies when the device was released. The cause(s) of the difficulty reported by the customer could not be determined. If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this or similar complaints. At present, we consider this complaint to be closed.
Patient Sequence No: 1, Text Type: N, H10
[139724819]
The customer states that the product appeared dirty prior to use and had residue that appeared to be blood on the pattie.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2019-10168 |
| MDR Report Key | 8415854 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-03-13 |
| Date of Report | 2019-02-20 |
| Date of Event | 2019-02-20 |
| Date Mfgr Received | 2019-02-20 |
| Date Added to Maude | 2019-03-13 |
| 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 | KAREN ANIGBO |
| Manufacturer Street | 11 CABOT BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 7819715608 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
| 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 1/2 X 3 |
| Generic Name | PATTIE, COTTONOID |
| Product Code | HBA |
| Date Received | 2019-03-13 |
| Catalog Number | 80-1407 |
| Lot Number | HX1397 / J0460D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-13 |