MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2015-12-17 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corporation.
[33752053]
It was reported a surgeon called a sales representative and stated he performed a surgery and placed a piece of integra (product) in a patient. He (the surgeon) was later informed by the hospital that the product was expired with an expiration date of 28oct2015. It was reported there was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[41363404]
Integra completed its internal investigation 2feb2016. The investigation included: method: review of device history records. Review of complaint management database for similar complaints. Results: no product lot number was provided with this complaint; therefore, dhr review cannot be performed. If the product lot number is provided at a later date, dhr review will be performed and updated at that time. It should be noted that all lot batch records are reviewed prior to lot release and any oos/issues are escalated to event/nonconformance as applicable. Additionally, since a lot number was not provided, the expiry date or the date of manufacture cannot be confirmed. A query of the complaints database for the timeframe of 12 months (from 20nov2014 to 20nov2015) was performed using the keywords? Expiry? And? Expiration? For the skin product family. (b)(4). The only specification given regarding the complaint product is that it is within the idrt family, which includes idrt-ts, idrt-sl, and idrt-meshed products. (b)(4). Conclusion: the most probable cause of this complaint is the customer? S inventory management system. The expiration date of the idrt product used in surgery was likely not checked prior to surgery and use. The expiration date for idrt products is calculated as 24 months from the start of manufacturing, not as 12 months after the start of packaging. The lot number and expiration date of each idrt product are clearly labeled on the outer box as well as on a patient sticker label, which is placed on the inner tyvek pouch. As described by the queries above, there have been no reported instances of mislabeling expiration dates so it is probable that the surgeon did use expired idrt product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2015-00031 |
| MDR Report Key | 5306263 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2015-12-17 |
| Date of Report | 2015-11-20 |
| Date of Event | 2015-11-20 |
| Date Mfgr Received | 2016-02-02 |
| Date Added to Maude | 2015-12-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT, UNKNOWN |
| Generic Name | INTEGRA |
| Product Code | MGR |
| Date Received | 2015-12-17 |
| Catalog Number | XXX-IDRT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-17 |