MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-08-15 for RANEY SCALP CLIPS 20-1037 manufactured by Codman & Shurtleff, Inc..
[82779782]
(b)(4). Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[82779783]
As reported by the ous affiliate, during surgery, the nurse opened 3 packs and found out there are 29pc in total instead of 30pc. Later on, same lot from different boxes were inspected and it was found that there is 11 pc in one of the packs from another box with same lot. There were no reports of delays; to resolve the issue, another pack was opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2017-10612 |
| MDR Report Key | 6795013 |
| Report Source | FOREIGN |
| Date Received | 2017-08-15 |
| Date of Event | 2017-08-03 |
| Date Mfgr Received | 2017-08-29 |
| Date Added to Maude | 2017-08-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JAMES KENNEY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282726 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RANEY SCALP CLIPS |
| Generic Name | CLIPS, SCALP |
| Product Code | HBO |
| Date Received | 2017-08-15 |
| Returned To Mfg | 2017-08-08 |
| Catalog Number | 20-1037 |
| Lot Number | FG613 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-08-15 |