MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-09-05 for RANEY SCALP CLIPS 20-1037 manufactured by Codman & Shurtleff, Inc..
[17031875]
It was reported that scalp clip caused tissue necrosis which resulted in need for second surgery to remove necrotic tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2001-00155 |
| MDR Report Key | 349919 |
| Report Source | 05,06 |
| Date Received | 2001-09-05 |
| Date of Report | 2001-08-08 |
| Date Mfgr Received | 2001-08-08 |
| Date Added to Maude | 2001-09-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2001-09-05 |
| Model Number | NA |
| Catalog Number | 20-1037 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 339226 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US |
| Baseline Brand Name | RANEY SCALP CLIPS |
| Baseline Generic Name | CLIPS, SCALP |
| Baseline Model No | NA |
| Baseline Catalog No | 20-1037 |
| Baseline ID | NA |
| Baseline Device Family | RANEY SCALP CLIPS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-09-05 |