FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN SUTURE PRODUCT
MDR report key: 2191811
·
Received July 28, 2011
Report
- Report Number
- 2210968-2011-01009
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Report Date
- July 7, 2011
- Manufacturer
- ETHICON, INC.
- Product Code
- GAS
- PMA / PMN Number
- NI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(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.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN SUTURE PRODUCT | SUTURE | GAS | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |