MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-05-08 for SURG PAT XRAY 1/2X1/2 80-1400 manufactured by Codman & Shurtleff, Inc..
[21296495]
The rep reported that the pattie was misplaced during the surgery, however, when located the device was x-rayed and could not be seen under xray. In addition a device from another lot, not used in the case was also xrayed and could not be seen.
Patient Sequence No: 1, Text Type: D, B5
[21401201]
It has been communicated that the device is not available for evaluation. Without the device it is not possible for codman to conduct a proper investigation. Since a lot number has been provided a review of the manufacturing records have been conducted and they revealed that the device conformed to all manufacturing and quality testing/inspection specifications prior to being released to stock. If at some point the device is returned for evaluation this complaint will be re-opened and investigated. Based on this evaluation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed. Please note that a therapy date has been specified as it is a required field. We do not use therapy dates and as a result today's date was used. (b)(4): device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2013-16737 |
| MDR Report Key | 3099549 |
| Report Source | 08 |
| Date Received | 2013-05-08 |
| Date of Event | 2013-04-18 |
| Date Mfgr Received | 2013-04-18 |
| Date Added to Maude | 2013-05-08 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURG PAT XRAY 1/2X1/2 |
| Generic Name | SURGICAL SPONGE |
| Product Code | FQA |
| Date Received | 2013-05-08 |
| Catalog Number | 80-1400 |
| Lot Number | 184407 |
| 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 | 1. Required No Informationntervention | 2013-05-08 |