MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for RANEY SCALP CLIPS 20-1037 manufactured by Codman & Shurtleff, Inc..
[115777915]
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
[115777916]
It was reported that the raney scalp clip container had more than expected. There were 11 products were enclosed in a box instead of 10 products with in the box. It was confirmed at the medical device agent. There is no report of patient harm. No further information was provided by hospital. The product will be returned to your site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2018-10538 |
| MDR Report Key | 7738560 |
| Date Received | 2018-08-01 |
| Date of Report | 2018-07-09 |
| Date of Event | 2018-07-09 |
| Date Mfgr Received | 2018-10-23 |
| Date Added to Maude | 2018-08-01 |
| 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 | MS 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 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RANEY SCALP CLIPS |
| Generic Name | CLIPS, SCALP |
| Product Code | HBO |
| Date Received | 2018-08-01 |
| Returned To Mfg | 2018-08-23 |
| Model Number | 20-1037 |
| Catalog Number | 20-1037 |
| Lot Number | MJ657 |
| 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 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-01 |