MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature,study report with the FDA on 2015-11-11 for SURGICAL PATTIE, 1/2 X 1/2 80-1400 manufactured by Codman & Shurtleff, Inc..
[30987836]
It has been communicated that the device and/or lot information is not available for evaluation. Without the device and/or lot information it is not possible for codman to conduct a proper investigation. If at some point the device and/or lot information 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
[30987837]
In the literature article? Radiographic detectability of retained neuropathies in a cadaver model? (2015) 84, 2:405-411, http://dx. Doi. Org/10. 1016/j. Wneu. 2015. 03. 032, it was reported that codman neuro patties in sizes? X? And? X? Had in adequate radiopacity. Counts are the commonest method used to ensure that all sponges and neuropathies are removed from a surgical site before closure. When the count is not reconciled, plain radiographs of the operative site are taken to determine whether the missing patty has been left in the wound. The purpose of this study was to describe the detectability of commonly used neuropathies in the clinical setting using digital technologies. Three surgical sites were chosen: the anterior cranial fossa, the posterior cranial fossa, and the thoracolumbar extradural space. Each operative site was draped in the usual manner with drapes being secured with surgical staples to simulate typical intraoperative artifacts. Craniotomies and laminectomies were performed to allow access for the placement of the neuropathies. Neuropathies (the four products tested in our study were, codman (raynham, ma) surgical patties: 80-1399 1/4 _ 1/4 in [64 _ 64 cm]; 80-1400 1/2 _ 1/2 in [1. 27 _ 1. 27 cm]; 80-1406 1/2 _ 2 in [1. 27 _ 5. 06 cm]; 80-1408 1 _ 3 in [2. 54 _ 7. 62 cm]) were implanted in randomized combinations into each surgical site and positioned in clinically relevant subregions as described. Under simulated operating room conditions and using currently available neuropathies and plain radiograph imaging technology, small 1/4-in and 1/2-in neuropathies are poorly visible/detectable on digital images. At the time of complaint entry there are no known lot numbers and the devices are not available for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2015-10658 |
| MDR Report Key | 5216980 |
| Report Source | FOREIGN,LITERATURE,STUDY |
| Date Received | 2015-11-11 |
| Date of Event | 2015-08-01 |
| Date Mfgr Received | 2015-10-19 |
| Date Added to Maude | 2015-11-11 |
| 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 | 2015-11-11 |
| Catalog Number | 80-1400 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-11-11 |