FDA Adverse Event
Malfunction
Summary report: N
PROLENE POLYPROPYLENE SUTURE
MDR report key: 76619
·
Received March 14, 1997
Report
- Report Number
- 2210968-1997-00052
- Event Type
- Malfunction
- Date Received
- March 14, 1997
- Report Date
- February 13, 1997
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ETHICON ELECTED TO TEST ALL RETURNED LOT NUMBERS. SAMPLES OF THE RETURNED PRODUCT WERE TESTED FOR KNOT PULL TENSILE STRENGTH AND THE RESULTS OBTAINED WERE ABOVE THE ETHICON REQUIREMENTS. WHICH ALWAYS EQUAL OR EXCEED THE MINIMUM USP REQUIREMENTS. A PRODUCT INQUIRY RECORDS REVIEW WAS CONDUCTED AND THERE HAVE BEEN NO OTHER INQUIRIES OF ANY TYPE RECEIVED INVOLVING THIS BATCH NUMBER.
Description of Event or Problem · 1
SUTURE BREAKAGE. CUSTOMER REPORTS THAT SUTURE BROKE DURING SURGERY. SURGICAL PROCEDURE AND DATE ARE UNSPECIFIED. THERE ARE NO ALLEGED CONSEQUENCES TO THE PT. NOTE: OUTCOME TO PT DOES NOT DENOTE ADVERSE EVENT. MDR REGULATION OF 7/31/96 REQUIRES REPORTING OF INCIDENT ONCE MEDICAL DEVICE FAMILY INITIALLY REPORTED ASSUMING INCIDENT COULD RECUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLENE POLYPROPYLENE SUTURE Implant | NON-ABSORBABLE SUTURE | GAW | ETHICON INC. | N/A | JBE607 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |