MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-17 for SURGICAL PATTIE, 1/2 X 1/2 80-1400 manufactured by Codman & Shurtleff, Inc..
[75371412]
(b)(4). Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[75371413]
As reported by (b)(6), surgical patties are leaving alot of fiber during surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
[76441642]
The complaint sample was not returned to codman for evaluation; therefore, the evaluation could not be performed and the root cause of this complaint could not be determined. In the absence of the complaint sample, a complaints records review was conducted. The dhr/manufacturing lot traveler was pulled and reviewed for lot h43025. All information on the traveler indicates that the product was produced within specifications. Therefore root cause could not be determined. No corrective action will be taken at this time. We will continue to monitor future complaints on this lot number for similar issues. Should the product be made available for evaluation at a later date we will re-open this complaint and evaluate the product. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2017-10333 |
| MDR Report Key | 6572919 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-17 |
| Date Mfgr Received | 2017-05-22 |
| Date Added to Maude | 2017-05-17 |
| 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 | 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 | SURGICAL PATTIE, 1/2 X 1/2 |
| Generic Name | SURGICAL SPONGE |
| Product Code | HBN |
| Date Received | 2017-05-17 |
| Catalog Number | 80-1400 |
| Lot Number | H43025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-05-17 |