MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-01-28 for SURGICAL PATTIE, 1/2 X 1/2 80-1400 manufactured by Codman & Shurtleff, Inc..
[4069351]
The sales rep reported: surgeon said the patties were fraying during the procedure. He could see them fray under the microscope.
Patient Sequence No: 1, Text Type: D, B5
[11494639]
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 will be reviewed. We anticipate that the evaluation will reveal that the device conformed to specifications prior to release. If anything otherwise is found then a follow up report will be filed. If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is considered closed.
Patient Sequence No: 1, Text Type: N, H10
[30720067]
The product was not returned for an evaluation. Due to not being able to evaluate the product under question, it is not possible to determine the root cause of this complaint. A review of the devise history records for the subject device did not revealed any anomalies. These lot codes appear to have met all testing requirement, there were no anomalies noted during manufacturing process. Lot # 415306 was used to verify capability of a new branson ultrasonic welder. All pull test data was found to be acceptable. While there is variation inherent in our manufacturing process of the cottonoid material, our objective is to produce product with the least possible amount of linting. Therefore lot to lot variation in the cottonoid process may result in lots that lint more or less than the norm. "fraying" can also come from the quality of the edge cut from the slitting process, but it is not possible to determine this is an issue since it is not possible to evaluate the product under question. We will continue to monitor for this or similar complaints for this product code. At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be reopened and an investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2014-11182 |
| MDR Report Key | 3594928 |
| Report Source | 07 |
| Date Received | 2014-01-28 |
| Date of Event | 2014-01-16 |
| Date Mfgr Received | 2014-04-01 |
| Date Added to Maude | 2014-01-28 |
| 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. 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 | FQA |
| Date Received | 2014-01-28 |
| Catalog Number | 80-1400 |
| Lot Number | 424137, 415306, 424140 |
| 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 | 2014-01-28 |