|
Model Number 9008G |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Inflammation (1932)
|
Event Date 07/12/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.The international affiliate reports the following possible batch number: kkr487.Mfg.Date: 09/13/1997, exp.Date: 12/31/2003.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.
|
|
Event Description
|
It was reported that a patient underwent a c-section procedure on (b)(6) 2019 and suture was used.It was reported that on (b)(6) 2019, the patient's incision got red and she suffered inflammation.Spectrum was given to the incision, and then bactroban and mirabilite were used on the patient to strengthen anti-inflammatory treatment.The patient condition then changed better.The physician opines that the contributing factors to this event was the poor healing of the abdominal incision.Additional information has been requested.
|
|
Manufacturer Narrative
|
(b)(4).Additional information was requested and the following was obtained: please confirm: is the product code involved is 9008g? unk, this case is from health authority, the information reported by hospital is lot number kkr487, no product code provided.The manufacturing records for lot kkr487 indicate that the expiration date is 12/31/2003 and manuf date is 9/13/1997.Please confirm: is the lot number involved kkr487? unk, this case is from health authority, the information reported by hospital is lot number kkr487.
|
|
Search Alerts/Recalls
|
|
|