FDA Adverse Event
Malfunction
Summary report: N
VICRYL RAPIDE (POLYGLACTIN 910) SUTURE
MDR report key: 1120109
·
Received August 14, 2008
Report
- Report Number
- 2210968-2008-00693
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- July 9, 2008
- Report Date
- July 16, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K033746
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DATE SENT TO THE FDA: 08/14/2008. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Description of Event or Problem · 1
INTERNATIONAL CUSTOMER REPORTED THAT A NEEDLE BROKE DURING AN EPISIOTOMY CLOSURE. THE NEEDLE FRAGMENT REMAINED IN-SITU. UNKNOWN IF THE RETAINED FRAGMENT HAS BEEN EXCISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VICRYL RAPIDE (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |