Catalog Number 24-5432 |
Device Problem
Material Frayed (1262)
|
Patient Problem
No Information (3190)
|
Event Date 07/20/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device was returned for evaluation.
Upon completion of the investigation a follow up report will be filed.
|
|
Manufacturer Narrative
|
The product was returned for evaluation.
This product is documented in the ifu as low linting.
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.
Lot number not reported therefor no dhr review could be completed and tcr could not be opened.
The most recent complaint and smt presentation has been reviewed and this product family did not exceed the upper control limit for complaints.
|
|
Manufacturer Narrative
|
(b)(4).
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.
|
|
Event Description
|
As reported by the distributor, surgical strips were linting.
|
|
Search Alerts/Recalls
|