FDA Adverse Event
Injury
Summary report: N
PDS II (POLYDIOXANONE) SUTURE
MDR report key: 3970485
·
Received July 31, 2014
Report
- Report Number
- 2210968-2014-10486
- Event Type
- Injury
- Date Received
- July 31, 2014
- Date of Event
- July 11, 2014
- Report Date
- July 14, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- NEW
- PMA / PMN Number
- N18331
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL HYSTERECTOMY ON (B)(6) 2014 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE DURING THE PROCEDURE AND WAS NOT RETRIEVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447443 | PDS II (POLYDIOXANONE) SUTURE | SUTURE, SURGICAL, ABSORBABLE | NEW | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |