MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-07-25 for APLIGRAF manufactured by Organogenesis, Inc..
[16861704]
On (b)(6) 2014 organogenesis qa complaints coordinator received a call from (b)(6) which stated that a patient of dr (b)(6) had presented with a suspected contamination that was possibly pseudomonas. No further details were provided at that time and no information was available regarding the treatment of this patient with apligraf. On (b)(6) 2014 after conducting follow up with the physician, the msl submitted a report via email that was completed with an organogenesis field sales representative. This report summarized (b)(6) follow up with dr (b)(6). Based on the report, the patient's first application of apligraf was performed by dr (b)(6) on wednesday, (b)(6) 2014. The patient returned for a follow up visit one week later and presented with green drainage around the edges of the wound. In dr (b)(6) opinion, the apligraf was still visible. Based on the appearance of the wound, dr (b)(6)suspected there may be a pseudomonas contamination but did not do either a qualitative or quantitative culture for organism identification or bioburden. According to the report, dr (b)(6) debrided the loose non-viable slough and wiped away the discolored, draining exudate. Observation of the suspected contamination was first made on (b)(6) 2014 and it was decided that the second apligraf application planned for that day would not be performed. Instead, the physician decided to wait one more week to evaluate the wound bed. No additional symptoms were noted and no additional treatment information was provided in the report. No patient identifying and or demographic information were reported. According to the report, the apligraf unit was applied per the instructions for use, and all fda approved criteria including storage, handling and visual were met. Specifically, visual examination of the apligraf unit showed the product to be within normal limits of the ph range consistent with aseptic processing and no bacterial contamination.
Patient Sequence No: 1, Text Type: D, B5
[17078305]
Apligraf lot# gs1404. 08. 01. 1a ((b)(4)) was packaged and transferred to shipping on 04/30/2014. Review of the device history record for this lot indicated that all required documentation and review signatures were completed prior to transfer of the lot to shipping. Histology samples from this lot met device specifications at 10 days pal on 04/28/2014 and histology testing documentation was reviewed by qa on 04/29/2014. At the time of this report, all final sterility and mycoplasma results were negative. Endotoxin testing passed and was reviewed by qa on 05/01/2014. The lot met all specifications and release criteria for shipment. This shipment of apligraf was shipped to the customer on (b)(4) 2014. On june 25, 2014 the organogenesis msl conducted an in-person, follow-up visit with dr (b)(6). Dr (b)(6) reported that the suspected pseudomonas contamination was improving, with antimicrobial dressings and debridement. It was further reported that the patient had a history of contamination which was slowing the healing process. Dr (b)(6) had decided to wait until next follow-up visit to determine whether to treat with apligraf again. The available information for this event was reviewed by (b)(4), m. D. , organogenesis medical consultant and assessed as mild severity. Relationship of the event to the product is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221816-2014-00004 |
| MDR Report Key | 3987918 |
| Report Source | 07 |
| Date Received | 2014-07-25 |
| Date of Report | 2014-07-25 |
| Date of Event | 2014-05-21 |
| Date Mfgr Received | 2014-05-30 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2014-08-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PATRICK BILBO |
| Manufacturer Street | 150 DAN RD. |
| Manufacturer City | CANTON MA 02021 |
| Manufacturer Country | US |
| Manufacturer Postal | 02021 |
| Manufacturer Phone | 7814011155 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APLIGRAF |
| Generic Name | NONE |
| Product Code | MGR |
| Date Received | 2014-07-25 |
| Lot Number | GS1302.21.01.1A |
| Device Expiration Date | 2014-05-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGANOGENESIS, INC. |
| Manufacturer Address | CANTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-25 |