MalfunctionGAS
UNKNOWN SUTURE PRODUCT
Received Jul 28, 2011
Report 2210968-2011-01009 · MDR key 2191811
Device
Product problems
- Needle, separation
Patient
NI
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PT UNDERWENT A SURGICAL PROCEDURE ON AN UNK DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE AND BECAME LOST IN THE PT. ADDITIONAL INFO HAS BEEN REQUESTED.
Additional Manufacturer Narrative
(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED, IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.